Account Manager (Medical Device Manufacturing) Job at Randstad (Johor)

Vice President, Research & Development

The VP of Research and Development (R&D) is responsible for defining and executi...

Location

United States , Alpharetta

Salary:

220000.00 - 265000.00 USD / Year

Avanos

Expiration Date

Until further notice

Requirements

Bachelor’s degree in an Engineering or Life Sciences field
Minimum of 15 years of experience in Engineering within the medical device industry
At least 7 years in a leadership or managerial role
Strong knowledge of medical device development processes, including design controls, risk management, and regulatory standards (FDA, ISO 13485, IEC 60601, etc.)
Proven track record of successfully managing cross-functional teams in the development of complex medical devices and bringing Class II or III medical devices from concept to launch
Strong understanding of regulatory, quality, and clinical interface in a global medical device environment
Proven track record of successfully managing relationships with contract designers and manufacturers in the development of complex medical devices
Expertise in systems engineering methodologies, including requirements management, system architecture design, integration, and testing
Experience developing business cases and facilitating project updates to leadership team
Financial and strategic acumen, being able to evaluate trade-offs between innovation, cost, and time to market

Job Responsibility

Defines the innovation roadmap, prioritizing opportunities based on unmet clinical needs, market potential, and technical feasibility
Establishes and maintains a strong R&D governance model (Product Development Process stage gates) ensuring disciplined portfolio management and timely decision-making
Oversees all phases of new product development, including concept, feasibility, design and development, verification and validation, design transfer, and post-market stability
Drives excellence in design controls, risk management, human factors, and process validations
Ensure alignment between R&D, Commercial, Operations, Quality, Clinical and Regulatory to facilitate launch readiness
Promotes the development of relationships with external designers and manufacturers that bring capabilities and capacity that support our strategy
Partners with universities, external research groups, suppliers, contract designers and manufacturers, and others to expand the company’s innovation network
Fosters a culture of innovation that balances speed, quality and compliance
Builds and develops a high-performing R&D organization with a clear succession, career development plans, and goals and objectives
Ensures that R&D activities comply with global regulatory and quality system requirements (FDA 21 CFR 820, ISO 13485, MDR, and MDSAP)

What we offer

Incentive compensation program
Comprehensive and competitive range of benefits
Health care benefits
Retirement plans
Work/life benefits
Generous 401(k) employer match of 100% of each pretax dollar you contribute on the first 4% and 50% of the next 2% of pay contributed with immediate vesting
Benefits on day 1
Free onsite gym
Onsite cafeteria
Uncapped sales commissions

Fulltime

Senior Director of Engineering, Maintenance, and Facilities

Accountable for all aspects of Engineering, Instrumentation and Controls, Utilit...

Location

United States , Bedford, NH

Salary:

Not provided

PCI Pharma Services

Expiration Date

Until further notice

Requirements

Operational background in cGMP environment, preferably in aseptic manufacturing/engineering
Demonstrated skill in managing a diverse population of professional, technical, and hourly personnel as well as external resources
Experience in working with regulators during inspections/audits is highly desired
10-12 years of experience in the field of technical engineering support to biopharma/pharm and/or medical device facilities
8-10 years of experience in management of professional and technical staff with accountability for objectives and subsequent evaluation
5-8 years of experience with engineering and maintenance support to biopharma/pharm and/or medical device facilities
5 years of experience managing managers with accountability for objectives and subsequent evaluation
Experience with company financial systems and an understanding of accounting practices and financials a plus
Experience with direct exposure to Customers in a CDMO business is a plus
Bachelor's degree in engineering discipline required

Job Responsibility

Accountable for all aspects of Engineering, Instrumentation and Controls, Utilities, Facilities, and Maintenance in supporting pharmaceutical and medical device product manufacturing across the PCI Manchester and Bedford, NH campus
Provide leadership to ensure the highest level of quality and adherence to cGMPs across the site
Responsible for managing people, providing quality and technical direction, and actively participating in driving and developing strategies for continuous improvement within the department
Manages and oversees all areas of process engineering, automation, calibration, facilities, operation of utilities including HVAC, buildings and ground maintenance, and maintenance of utilities and facilities supporting aseptic operations and non-aseptic medical device manufacturing activities across multiple plants
Responsible for management of CAPEX projects
Ensures all aspects engineering and facilities are adhering to cGMPS and PCI’s established SOPs
Ensures all projects are executed safely, on time, and within budget
Identifies, prepares and leads small CAPEX projects
Responsible for all aspects of Engineering, Instrumentation and Controls, Utilities, Facilities, and Maintenance programs
Determine appropriate equipment, line, tooling, costs and capacities for new projects or changes to existing projects

Fulltime

New

Account Manager (Electronics Manufacturing Services)

This high-impact commercial position serves as the pivotal strategic bridge betw...

Location

Malaysia , Johor

Salary:

7000.00 - 11000.00 MYR / Year

Randstad

Expiration Date

June 18, 2026

Requirements

Minimum of 5 years of experience in sales, program management, or key account management within an industrial manufacturing environment
Proven track record of guiding advanced components through the complete New Product Introduction lifecycle
Strong technical proficiency in reviewing technical drawings, calculating product costing, and applying Design for Manufacturing principles
Solid experience operating within the OEM/CM market, with specific exposure to electronics or medical device manufacturing being highly advantageous

Job Responsibility

Identify, source, and capture new commercial opportunities within advanced manufacturing sectors to grow regional market share
Lead cross-functional engineering teams through the management of quotations, project timelines, and complex engineering change requests
Collaborate with internal production teams on Design for Manufacturing reviews and the translation of detailed technical drawings
Nurture deep-rooted commercial relationships with key external stakeholders, procurement partners, and international project owners
Formulate competitive pricing models and contract proposals based on rigorous market research and internal product costing data
Oversee sales forecasting and pipeline metrics while coordinating with regional manufacturing sites to secure timely sample readiness

What we offer

Allowance
Bonus

New

Standardized Cost Manager

Our client, a growing healthcare manufacturing organization, is seeking a highly...

Location

United States , New York

Salary:

130000.00 - 170000.00 USD / Year

Solomon Page

Expiration Date

Until further notice

Requirements

Bachelor's degree in Accounting, Finance, Supply Chain, or related field required
5+ years of experience within standard cost accounting or standardized costing functions in a manufacturing environment
Healthcare manufacturing, medical device, pharmaceutical, or highly regulated manufacturing experience strongly preferred
Strong expertise in standard costing methodologies, BOM structures, routings, and manufacturing variance analysis
SAP experience highly preferred
Experience managing large-scale cost roll-ups and ERP master data maintenance
Strong understanding of inventory accounting and high-volume manufacturing operations
Advanced Excel and ERP systems experience required
Ability to build processes and drive operational improvements in a fast-paced environment
Strong communication skills with the ability to partner across both finance and operations teams

Job Responsibility

Own and manage the company's standardized costing function across manufacturing operations
Establish, maintain, and update standard costs for materials, labor, and manufacturing overhead
Build and implement scalable standardized costing processes and procedures from the ground up
Lead mass cost roll-ups and costing updates within the ERP system, preferably SAP
Maintain integrity of system master data including Bills of Materials (BOMs), routings, labor standards, and cost drivers
Develop standardized cost benchmarks to support inventory valuation, pricing, forecasting, and operational planning
Analyze and report on manufacturing variances including material, labor, overhead, purchase price, yield, and production variances
Partner cross-functionally with Operations, Supply Chain, Engineering, Procurement, and Finance to improve costing accuracy and manufacturing efficiency
Transition highly manual costing processes into more automated and system-driven workflows
Support inventory management initiatives including cycle counts, inventory reconciliation, and reserve analysis

What we offer

Relocation assistance

Fulltime

Accounting Manager

Robert Half is currently recruiting for an Accounting Manager opportunity with a...

Location

United States , Clearwater

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

Bachelor's degree in Accounting required
Prior accounting management or supervisory experience required
Strong accounting, financial reporting, analytical, and problem-solving skills
Ability to communicate effectively with accounting, operations, leadership, and external audit teams
Strong organizational skills, attention to detail, and ability to manage deadlines
Hands-on approach with the ability to both perform accounting work and oversee the work of others
CPA or CPA eligibility is a plus
Public accounting audit experience is a plus
Public company, internal controls, or SOX experience is a plus
Manufacturing, medical device, or related product-based industry experience is a plus

Job Responsibility

Oversee the accounts receivable function, including AR aging, collections activity, customer issues, and related reporting
Manage and support accounting team members, including staff accounting and credit/collections personnel
Prepare and review accounting work with a focus on accuracy, timeliness, and adherence to company policies and controls
Support month-end, quarter-end, and year-end close activities
Assist with accounting areas such as cash, prepaid expenses, intercompany activity, consolidations, stock compensation, and other areas as needed
Prepare periodic and ad hoc financial reports for management
Support internal and external audits, including documentation, analysis, and issue resolution
Partner with personnel outside of accounting to research issues, improve processes, and provide financial information
Help maintain strong internal controls and support a public company reporting environment

What we offer

medical
vision
dental
life and disability insurance
401(k) plan

Fulltime

New

Group Regulatory Affairs Specialist Class II

At Ontex, we are making everyday life easier across generations. Worldwide our 5...

Location

Germany , Grosspostwitz

Salary:

Not provided

Ontex Peninsular

Expiration Date

Until further notice

Requirements

Master’s degree (university or equal through experience) in science
In-depth knowledge of US and Canada regulations, standards, and guidance documents for medical devices
Knowledge of quality management systems and medical device standards such as ISO 13485, ISO 14971
Minimum of 3 years experience in Regulatory Affairs for medical devices
Experience in 510k submission
Experience or interest in regulatory affairs for Software as Medical Device (SAMD)
Experience in working with cross-functional teams and building strong relationships across departments
Ability to integrate and demonstrate core values, integrity and accountability throughout the organization and externally
Ability to lead, manage, collaborate and communicate within the organization, with groups engaged in the development of good regulatory practice and policy, and within the regulatory profession

Job Responsibility

Researches and determines requirements for regulatory submissions, approval pathways and compliance activities
Monitor and evaluate the regulatory environment and provide internal advice
Supervises data input activities and provides impact analysis
Identifies the need for new regulatory procedures and SOPs
Identifies requirements for market access and distribution
Evaluates proposed preclinical, clinical and manufacturing documents for regulatory filing
Actively contribute in assessing the impact of new guidance and regulations
Provides regulatory input and technical guidance on global regulatory requirements
Advises stakeholders of regulatory requirements for quality, preclinical and clinical data
Works with cross-functional teams for interactions with regulatory authorities

What we offer

Permanent employment contract in a future-proof company bound by collective agreements
Attractive remuneration and comprehensive social benefits
Holiday and Christmas bonuses
30 days of holiday
Company pension scheme
Corporate benefits and discounts
Exciting and varied working environment

Fulltime

Senior Cost Accountant

The Senior Cost Accountant provides accurate, timely cost accounting and analysi...

Location

United States , Charlton

Salary:

73600.00 - 95600.00 USD / Year

KARL STORZ

Expiration Date

Until further notice

Requirements

Bachelor's degree in Accounting, Finance, or related field
5+ years of accounting experience, including 1+ year in cost accounting within a manufacturing environment
Strong working knowledge of standard costing, absorption costing, and inventory accounting, including relevant G/L and financial accounting concepts in a standard cost environment
Hands-on SAP experience (preferred): CO (Production Orders), CK (Material Costing), KP (Activity Costs), and MM (Materials Management)
Advanced Excel skills (pivot tables, lookups, and data analytics)
Experience in a regulated industry (medical devices or similar)
Strong analytical, problem-solving, and communication skills
Knowledge of GAAP

Job Responsibility

Provide accurate, timely cost accounting and analysis to support manufacturing operations and business decision-making in a medical device environment
Support monthly cost accounting close: inventory valuation reporting, journal entries, and reconciliations
Maintain standard costs for raw materials, WIP, and finished goods in SAP
Analyze and communicate manufacturing variances (PPV, labor/overhead absorption, scrap) and partner with operations on corrective actions
Review and recommend improvements to BOM and routing accuracy
collaborate cross-functionally on ECN-related cost impacts
Assist with cost rolls, annual standard cost updates, and revaluation as part of budgeting and standard setting
Identify opportunities for process improvement and automation within SAP cost accounting and reporting workflows
Provide required documentation and analysis to support internal and external audits
Serve as a backup SME for SAP Costing and related areas

What we offer

Medical / Dental / Vision including a state-of-the-art wellness program and pet insurance
3 weeks vacation, 11 holidays plus paid sick time
Up to 8 weeks of 100% paid company parental leave
includes maternal/ paternal leave, adoption, and fostering of a child
401(k) retirement savings plan providing a match of 60% of the employee's first 6% contribution (up to IRS limits)
Section 125 Flexible Spending Accounts
Life, STD, LTD & LTC Insurance
Tuition pre-imbursement up to $5,250 per year
Fitness reimbursement of up to $200 annually

Fulltime

New

Program Manager

The Program Manager plays a critical leadership role in the development and comm...

Location

United States , Burlington

Salary:

150000.00 - 165000.00 USD / Year

Myomo

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Engineering (Biomedical, Mechanical or Electrical/Software) or life sciences (Biology, Chemistry) preferred, or similar
7+ years of experience working as a Project Manager developing products
5+ years managing projects within medical device, biotechnology or pharmaceutical industries preferred
Ability to effectively manage and prioritize multiple workstreams and work independently with minimal supervision
Critical thinking, analytical and problem-solving abilities
Excellent verbal/written communication and organizational skills
3+ years working in a product development environment (Desirable)
3+ years working with electromechanical systems (Desirable)
PMP Certification (Desirable)

Job Responsibility

Lead cross-functional development activities supporting Myomo’s next generation flagship electro-mechanical orthotic product platform through all phases of the product lifecycle
Drive execution across complex hardware and software development efforts
Partner closely with the Director of Project & Product Management to ensure programs are appropriately staffed and resourced
Coordinate and align cross-functional teams including Engineering, Clinical, Manufacturing/Operations, Marketing, Sales, Quality, and Regulatory to achieve program objectives and business milestones
Own integrated program planning, timelines, resource coordination, budget tracking, and risk management
Lead program execution through Myomo’s phase-gate and design controls processes
Facilitate effective communication, decision-making, and accountability across all levels of the organization
Partner with Product Management to translate customer, clinical, and business needs into actionable product development priorities and execution plans
Ensure Manufacturing is actively engaged throughout development
Identify program risks, develop mitigation strategies, and proactively resolve technical and operational challenges

Fulltime

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Account Manager (Medical Device Manufacturing)

Job Description

Job Responsibility

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What we offer

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