Senior Program Manager- Medical Device Job at Avanos (Alpharetta)

Senior Medical Device Compliance Engineer

The Senior Medical Device Compliance Engineer is responsible for medical device ...

Location

United States

Salary:

130500.00 - 159500.00 USD / Year

SharkNinja

Expiration Date

Until further notice

Requirements

Bachelor's or Master's degree in Engineering (Mechanical, Electrical, Biomedical), Quality, or a related technical discipline
5+ years of experience in design controls, and post-market sustaining of medical devices
Strong experience supporting electromechanical medical devices, preferably within consumer electronics or high-velocity product development environments
Deep expertise in design controls and risk management, including ISO 14971, hazard analysis, DFMEA, requirements management, and verification/validation
Experience supporting post-market design changes, including ECNs, root cause analysis, and lifecycle risk management
Experience working with overseas contract manufacturers and distributors, including qualification, process validation review, and ongoing compliance oversight
Working knowledge of biocompatibility, electrical safety, labeling, and component change impact assessments
Strong communication skills and the ability to operate effectively in a complex, matrixed organization
Pragmatic, detail-oriented mindset suited to fast-paced, innovative-driven environments

Job Responsibility

Drive design control execution for multiple concurrent medical device NPD programs, ensuring high-quality, audit-ready technical documentation
Lead and support the creation, review, and approval of Design History Files (DHFs), including design and development plans, requirements, design reviews, risk management files, verification and validation plans and reports, and traceability, ensuring documentation is complete and submission ready
Translate medical device compliance and regulatory requirements into clear, actionable product and engineering requirements
Ensure risk management activities including hazard analysis, DFMEA, and test planning in alignment with QMS processes
Support post-market design changes by driving and reviewing ECNs, root cause analysis, risk reassessment, and associated verification/validation and documentation updates
Serve as a hands-on QMS Compliance leader within cross-functional teams, influencing execution through expertise, collaboration, and clear decision-making in a matrixed environment
Review supplier qualifications, process validations, and manufacturing documentation from OEMs to ensure compliance with medical device requirements
Support internal audits, supplier audits, and regulatory inspections

What we offer

medical insurance
dental insurance
vision insurance
flexible spending accounts
health savings accounts (HSA) with company contribution
401(k) retirement plan with matching
employee stock purchase program
life insurance
AD&D
short-term disability insurance

Fulltime

Senior Technical Program Manager - Product Development

We are looking for a Senior Technical Program Manager to join our Product Develo...

Location

Ireland , Dublin

Salary:

Not provided

ResMed

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Computer Science or related discipline preferred
7+ years of Program Management experience working directly with multiple agile, product and/or platform teams on hardware-enabled products or embedded devices is a strong plus
Strong understanding of the software development lifecycle and experience with hardware and embedded system development processes
Experience with agile software development tools such as Jira and Confluence
Excellent interpersonal, written and oral communication skills
Outstanding time management and organization skills
Adept in problem-solving, facilitating decision making and resolving conflict

Job Responsibility

Facilitate project and program-level processes, drive execution, escalate impediments, manage risks and help foster continuous improvement across, often international, projects and programs, involving hardware and software teams
Define project scope, set schedules, and ensure regular and timely delivery of value to end customers through all phases of the product development lifecycle, from early R&D through verification and launch
Address resource constraints, dependencies, and timing challenges while syncing efforts across teams (Biomedical Research, Product Managers, Embedded Engineering, Digital Software Engineering, V&V, Systems Engineering, Medical Affairs etc.)
Collaborate with product managers, engineering managers, program managers, and other stakeholders to ensure alignment with business commitments and sync points across teams
Manage and communicate the implementation of significant changes to planning objectives, schedules, and product configurations to internal and external stakeholders
Provide regular status updates, highlighting accomplishments, plans, and any issues across assigned programs
Perform work in a specialized area requiring a deep understanding of fundamental principles, themes, and concepts
Accept and manage changing priorities and address issues quickly and professionally

What we offer

bonus plan
Working from home flexibility occasionally
access to a referral bonus
access to Resmed's preferred shareholding programme
Internal career opportunity - joining an international fast-pace and massively growing company

Fulltime

New

Senior Manager, FLC

This is where new knowledge is discovered. Baxter's Research and Development tea...

Location

India , Bengaluru

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Bachelor's or Master's degree in Electrical/Electronics OR Mechanical OR Biomedical Engineering or related field
15+ years of experience in medical device or complex electro-mechanical product development
5+ years in functional leadership roles managing multi-disciplinary teams
Proven experience in global, matrixed R&D environments
Strong knowledge of: Electrical systems (electronics, embedded, control systems). Mechanical systems (materials, fluids, structures, plastics). System integration and verification methodologies
Deep expertise in electro-mechanical system design and integration
Strong people leadership, coaching, and organizational development skills
Ability to define and execute R&D strategies and influence senior stakeholders
Expertise in decision-making under ambiguity and complex problem-solving
Strong communication and stakeholder management skills

Job Responsibility

Define and execute the strategy for Hardware and Systems Verification functions, aligned with business and product roadmaps
Build, scale, and lead high-performing teams across Electrical, Mechanical, and V&V engineering disciplines
Drive organizational capability development, including talent pipeline, succession planning, and competency building
Influence global R&D strategies, technology roadmaps, and engineering best practices
Act as a technical and functional leader recognized across business units for programs of significant impact
Lead and oversee end-to-end product development lifecycle: Concept development, Architecture definition, Detailed design, Verification & validation, Transfer to manufacturing, Post-market sustainment
Ensure successful delivery of complex electro-mechanical systems integrating hardware, embedded software, and controls
Drive sustenance engineering, including root cause investigations, field issue resolution, and product enhancements
Partner with Program Management to ensure delivery within quality, cost, and schedule targets
Provide technical oversight across Electrical systems (mixed-signal, power electronics, sensors, control systems) and Mechanical systems (structural design, fluid management, plastics, disposables, simulation)

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

New

Senior Manager, Technical Support

This is where your work makes a difference. At Baxter, we believe every person—r...

Location

United States , Skaneateles Falls

Salary:

136000.00 - 187000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

6+ years of relevant experience
Experience working within regulated industries, healthcare, medical devices, life sciences, or other complex service environments is preferred
Bachelor's degree required
Detail-oriented, results driven, highly accountable
Excellent data analytical skills and strong financial acumen
Track record of leading continuous improvement, Lean, operational excellence, or cost-saving initiatives while maintaining a customer-first mindset
Proficiency with Microsoft Office Suite
Experience with ERP platforms such as SAP and/or JD Edwards is a plus

Job Responsibility

Lead and manage your human and capital resources to achieve all established targets
Identifying and developing the desired Customer Service culture for Front Line Care
Identify the key performance indicators for Customer Service and then putting the principles, programs, and monitoring capabilities in place to achieve those KPI's
Leading and furthering customer dedication by using NPS and other tools and tactics
Developing guidelines, policies and procedures which will drive continuous improvement
Partnering with Service leadership to build and implement the Service and Front-Line Care strategy
Identifying and executing against lean and or profit enhancement opportunities
Building and maintaining a collaborative relationship with Sales, Business Partners, Product Marketing, and other key collaborators throughout the enterprise

What we offer

Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP) with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP) with options for employee contributions and company matching
Flexible Spending Accounts
Educational assistance programs
Time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service
Family and medical leaves of absence
Paid parental leave
Commuting benefits

Fulltime

Quality Systems PMO Program Manager

Are you a strategic PMO leader looking to spearhead large-scale compliance and o...

Location

United Kingdom , Basingstoke

Salary:

27.00 GBP / Hour

Randstad

Expiration Date

July 02, 2026

Requirements

7+ years of experience managing complex global Quality Systems, PMO, or enterprise transformation programs
Proven background within highly regulated industries such as Life Sciences, Medical Devices, Diagnostics, Biotechnology, or Pharmaceuticals
Strong experience with enterprise QMS harmonisation, quality systems integration, and operational transformation
Demonstrated experience integrating Supplier Quality, Commercial QMS, Manufacturing Quality, or Distribution Quality processes
Experience supporting regulatory inspections, remediation programs, and compliance transformation initiatives
Background using Lean, Six Sigma, PPI, or other continuous improvement methodologies is preferred
Strong knowledge of Quality Management Systems, enterprise quality governance models, and digital quality software platforms
Deep technical understanding of core quality processes (CAPA, change control, audits, supplier quality, training, and document management)
Strong understanding of global quality regulations and standards including FDA, ISO 13485, GMP, and GDP
High-level stakeholder management and executive communication capabilities, with experience developing governance frameworks, dashboards, and KPIs

Job Responsibility

Program Leadership & Governance: Define program deliverable, timelines, governance structures, and success metrics for global QMS harmonisation initiatives. Orchestrate PMO reviews, steering committee meetings, and quality councils
QMS Integration & Harmonisation: Drive the integration of Distribution Centres and supplier quality processes into enterprise QMS frameworks. Support the standardisation of core quality processes including CAPA, Change Control, Document Control, Training, Audit Management, and Complaint Handling
Risk & Change Management: Identify, monitor, and mitigate program risks such as compliance gaps, operational disruptions, and integration challenges. Build alignment across business units to drive the adoption of harmonised standards and operating models
PMO Metrics & Reporting: Coordinate enterprise-wide inputs to build standardised reporting, KPI visibility, governance dashboards, and actionable quality insights for senior leadership
Inspection Readiness & Continuous Improvement: Lead cross-functional remediation and quality transformation initiatives to support regulatory inspections and internal audits. Use Lean, Six Sigma, and operational excellence methodologies to drive process optimisation and simplification

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Senior Manager, Health Economics & Value - Enterprise Corporate Accounts

As the Senior Manager, Health Economics & Value - Enterprise Corporate Accounts,...

Location

United States , Batesville

Salary:

160000.00 - 220000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Advanced degree in health economics, health policy, epidemiology, biostatistics, pharmacy, or a related discipline (Master's, PhD, PharmD) or equivalent experience preferred
5+ years of experience in HEOR, health economics, market access, or reimbursement strategy within medical devices, digital health, or hospital solutions preferred
Demonstrated experience developing economic models (ROI, budget impact, cost-effectiveness) and translating them into customer-ready tools
Strong understanding of U.S. healthcare provider economics, including VAC processes, quality metrics, and inpatient/outpatient dynamics
Experience with real-world evidence generation or outcomes measurement in a hospital setting
Experience partnering directly with health systems on pilots, quality improvement initiatives, or outcomes-based programs
Ability to tailor value stories to clinical, operational, and financial audiences, with strong provider economic fluency
Proven ability to lead programs, drive cross-functional alignment, and balance analytical rigor with real-world timelines and data constraints

Job Responsibility

Develop and implement health system value programs that define measurable clinical, operational, and financial outcomes tied to Baxter product adoption
Translate customer priorities into jointly agreed value demonstration activities, including implementation, analysis, and performance measurement
Lead cross-functional teams to shape customer-facing deliverables and ensure alignment across commercial, clinical, and operational stakeholders
Design and execute economic analyses credible to value analysis committees (VAC), clinical leaders, and purchasing stakeholders
Build and refine ROI tools and economic models across multiple care pathways, ensuring methodological rigor and transparency
Partner with internal and external stakeholders to ensure models reflect how health systems evaluate value (cost, labor, productivity, capacity, revenue)
Collaborate with marketing, commercial, and R&D teams to prioritize evidence needs and support strategic portfolio decisions
Support reimbursement strategy across the portfolio, including coding, coverage, payment considerations, and policy monitoring

What we offer

Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
Educational assistance programs
Time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave
Commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)

Fulltime

Senior Manager, Health Economics & Value - Enterprise Corporate Accounts

As the Senior Manager, Health Economics & Value - Enterprise Corporate Accounts,...

Location

United States , Batesville

Salary:

160000.00 - 220000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Advanced degree in health economics, health policy, epidemiology, biostatistics, pharmacy, or a related discipline (Master’s, PhD, PharmD) or equivalent experience preferred
5+ years of experience in HEOR, health economics, market access, or reimbursement strategy within medical devices, digital health, or hospital solutions preferred
Demonstrated experience developing economic models (ROI, budget impact, cost‑effectiveness) and translating them into customer‑ready tools
Strong understanding of U.S. healthcare provider economics, including VAC processes, quality metrics, and inpatient/outpatient dynamics
Experience with real‑world evidence generation or outcomes measurement in a hospital setting
Experience partnering directly with health systems on pilots, quality improvement initiatives, or outcomes‑based programs
Ability to tailor value stories to clinical, operational, and financial audiences, with strong provider economic fluency
Proven ability to lead programs, drive cross‑functional alignment, and balance analytical rigor with real‑world timelines and data constraints
Applicants must be authorized to work for any employer in the U.S.

Job Responsibility

Develop and implement health system value programs that define measurable clinical, operational, and financial outcomes tied to Baxter product adoption
Translate customer priorities into jointly agreed value demonstration activities, including implementation, analysis, and performance measurement
Lead cross‑functional teams to shape customer‑facing deliverables and ensure alignment across commercial, clinical, and operational stakeholders
Design and execute economic analyses credible to value analysis committees (VAC), clinical leaders, and purchasing stakeholders
Build and refine ROI tools and economic models across multiple care pathways, ensuring methodological rigor and transparency
Partner with internal and external stakeholders to ensure models reflect how health systems evaluate value (cost, labor, productivity, capacity, revenue)
Collaborate with marketing, commercial, and R&D teams to prioritize evidence needs and support strategic portfolio decisions
Support reimbursement strategy across the portfolio, including coding, coverage, payment considerations, and policy monitoring

What we offer

medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
educational assistance programs
time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service
family and medical leaves of absence
paid parental leave
commuting benefits

Fulltime

Senior Manager, Patient Safety

The Senior Manager, Medical Device end to end Management is a leadership role re...

Location

India , Hyderabad

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Experience in Patient Safety Services
demonstrated success in clinical, medical, or scientific domains
People management capabilities with experience leading teams
Experience in client relationship management
Understanding of pharmacovigilance operations, clinical research methodologies, and regulatory frameworks
Clinical experience with progressive responsibilities
Strong clinical, regulatory, and medical Patient Safety Services knowledge
Good understanding of ICH, CIOMS, GVP, and pharmacovigilance requirements
Familiarity with automation/AI in pharmacovigilance
Adaptable mindset with enthusiasm for learning

Job Responsibility

Lead the complete lifecycle of medical device complaint handling and post-market surveillance
Oversee FDA MDR reporting including 5-Day, 30-Day, and Supplemental Reports
Ensure high-quality investigations, root cause analysis, and CAPA linkage
Maintain compliance with 21 CFR 803, 820, ISO 13485, and internal QMS standards
Partner with Regulatory, Quality, R&D, and Manufacturing teams to manage product performance and patient safety insights
Support FDA inspections and internal/external audits
Manage and mentor a high-performing complaint operations team
Delegate work to Patient Safety staff according to allocated budget/hours
Coordinate with Solutions Consultant and/or regional Head of Safety Services as appropriate to assign resources to the project, and to assess staffing needs for current and future activities
Conduct interviews for recruitment of new personnel as necessary

Fulltime

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Senior Program Manager- Medical Device

Job Description

Job Responsibility

Requirements

Nice to have

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