Medical Device Engineer Lead Job at Proclinical (Brussels)

Director Systems Engineering, infusion systems, medical fluid management

As the Director Systems Engineering, Infusion Systems, you will lead the develop...

Location

United States , Round Lake

Salary:

184000.00 - 253000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor's or Master’s degree in Systems Engineering, Biomedical Engineering or a related field
Minimum of 10 years of experience in systems engineering, with a focus on medical fluid management devices (electromechanical pumps) in the medical device industry
Demonstrated experience leading, developing and managing engineering teams in a highly regulated environment
Strong technical skills, with a deep understanding of systems engineering principles and practices
Excellent communication and collaboration skills, with the ability to work effectively with cross-functional teams
Critical thinker, strong problem-solver, analytical
Proactive approach to project management, able to address potential risks and issues before they become critical
Organized, able to prioritize tasks effectively
Passionate about ensuring the safety and effectiveness of medical devices, and committed to delivering high-quality products that meet user needs
Customer focus, with a deep understanding of user needs and preferences, and a commitment to designing and developing products that meet these needs

Job Responsibility

Lead and develop global systems engineering teams based in Round Lake, IL, Bangalore, India, and Medina, NY
Create, effectively communicate and deploy the strategy for the team that aligns with the overall systems organization strategic plan
Own capturing system use environments, workflows, user needs and use cases across all infusion systems platforms
Lead systems design validation across all platforms
Drive creation and verification of comprehensive system requirements for new and existing infusion systems pumps, administration sets, elastomerics and accessories, ensuring they are complete, accurate, and aligned with user needs and business objectives
Collaborate to ensure alignment and traceability of requirements throughout the product development process
Implement and maintain a robust systems risk management framework to identify, analyze, and mitigate potential risks
Lead resource demand planning, allocation, and actuals
Recruit, mentor, and lead a multi-disciplinary engineering team, fostering a culture of innovation, collaboration, and continuous improvement
Conduct regular risk assessments and reviews ensuring compliance with medical device regulations and standards

What we offer

Support for Parents
Continuing Education/Professional Development
Employee Health & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
Medical and dental coverage starting day one
Basic life insurance
Accident insurance
Short-term and long-term disability insurance
Business travel accident insurance

Fulltime

Director Systems Engineering

As the Director Systems Engineering, Infusion Systems, you will lead the develop...

Location

United States , Round Lake

Salary:

184000.00 - 253000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor's or Master’s degree in Systems Engineering, Biomedical Engineering or a related field
Minimum of 10 years of experience in systems engineering, with a focus on medical fluid management devices (electromechanical pumps) in the medical device industry
Demonstrated experience leading, developing and managing engineering teams in a highly regulated environment
Strong technical skills, with a deep understanding of systems engineering principles and practices
Excellent communication and collaboration skills, with the ability to work effectively with cross-functional teams
Critical thinker, strong problem-solver, analytical
Proactive approach to project management, able to address potential risks and issues before they become critical
Organized, able to prioritize tasks effectively
Passionate about ensuring the safety and effectiveness of medical devices, and committed to delivering high-quality products that meet user needs
Customer focus, with a deep understanding of user needs and preferences, and a commitment to designing and developing products that meet these needs

Job Responsibility

Lead and develop global systems engineering teams based in Round Lake, IL, Bangalore, India, and Medina, NY
Create, effectively communicate, and deploy the strategy for the team that aligns with the overall systems organization strategic plan
Own capturing system use environments, workflows, user needs and use cases across all infusion systems platforms
Lead systems design validation across all platforms
Drive creation and verification of comprehensive system requirements for new and existing infusion systems pumps, administration sets, elastomerics, and accessories, ensuring they are complete, accurate, and aligned with user needs and business objectives
Collaborate to ensure alignment and traceability of requirements throughout the product development process
Implement and maintain a robust systems risk management framework to identify, analyze, and mitigate potential risks
Lead resource demand planning, allocation, and actuals
Recruit, mentor, and lead a multi-disciplinary engineering team, fostering a culture of innovation, collaboration, and continuous improvement
Conduct regular risk assessments and reviews ensuring compliance with medical device regulations and standards

What we offer

Support for parents
Continuing education/professional development
Employee health & well-being benefits
Paid time off
2 days a year to volunteer
Medical and dental coverage that starts on day one
Basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP) with company matching
Flexible Spending Accounts

Fulltime

Principal Supplier Quality Engineer

This position provides technical leadership for Supplier Quality Management proc...

Location

United States

Salary:

Not provided

Avanos

Expiration Date

Until further notice

Requirements

Personnel performing work affecting product quality shall be competent based on appropriate education, training, skills and experience.
B.S. in Engineering, Science, Business, or another relevant field
Minimum of 10 years of collective experience in a Research, Manufacturing, Quality and/or Regulatory Affairs function within a medical device, pharmaceutical, biologic, or other highly regulated industry.
Supplier Quality Engineering experience in the Medical Device industry
Strong understanding of Risk Management principles and techniques.
Knowledge of Statistical Techniques
Experience in root cause analysis and failure investigation tools
Working knowledge of the MDSAP Single Audit program including the regulations for US, Japan, Canada, Australia, and Brazil
Working knowledge of the key medical device compliance related standards such as ISO 13485, ISO 14971, ISO 19011, ISO 10993, etc.
Certification as CQA, CBA, MDA, or ISO 13485 Lead Auditor

Job Responsibility

Ensure conformance to industry practices, domestic and international regulatory requirements and established company procedures.
Provide global technical leadership in the development and implementation of quality and regulatory compliance strategies and best practices to ensure the manufacturing and distribution of products comply with applicable regulatory requirements.
Lead cross-functional collaboration with Procurement, R&D/Operations, Technical Quality, and Logistics teams to address quality issues at contract manufacturers and suppliers.
Establish and administer the supplier audit program for quality/regulatory compliance.
Maintain the Approved Supplier List (ASL).
Support the Global Supplier Review Board, including providing metrics for supplier assessments.
Actively engage with suppliers in the event of a supplier issue requiring corrective action or upcoming external audits.
Provide guidance as needed for corrective action required because of assessment findings.
Execute supplier audits in accordance with approved schedules.
Support documentation of supplier changes through the supplier notification, change management, QNC, or CAPA processes.

What we offer

comprehensive and competitive range of benefits
Total Rewards package
pay
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

Manufacturing Engineer

Eitan Medical is a fast-growing international medical device company that develo...

Location

Israel , Netanya

Salary:

Not provided

Eitan Medical

Expiration Date

Until further notice

Requirements

BSc in mechanical engineering from a well-known establishment
At least 5 years’ experience in manufacturing engineering at a multidisciplinary company
Good understanding of assembling and manufacturing processes (injection molding, machining, PCB manufacturing etc.)
Experience in the medical device industry and with FDA and ISO 13485 medical device regulations
Experience with single-piece flow manufacturing processes
Great problem-solving and debugging capabilities
Full control of all Microsoft Office applications
SolidWorks
Fluent English (written and verbal)
Strong technical and analytical skills

Job Responsibility

Production process establishments and improvements
Resolve the company products technical issues and continuously support and improve the products’ quality
Lead Engineering Change Orders (ECOs) in accordance with FDA/MDR regulations, including creating production files, defining assembly processes, writing work instructions, preparing drawings
Conduct technical investigations and experiments, drive for root cause identification
Perform verification and validation activities for the production line
Plan, specify, implement, and maintain dedicated tools, jigs, and production equipment

Fulltime

Principal Electrical Engineer

We are seeking a highly experienced and technically driven Principal Electrical ...

Location

United States , Plymouth

Salary:

Not provided

Blackrock Neurotech

Expiration Date

Until further notice

Requirements

B.S. in Electrical Engineering, Biomedical Engineering, or related field
10+ years of experience in electrical design for active implantable medical devices (AIMDs), such as neurostimulators, pacemakers, or cochlear implants
Proven track record designing low-noise analog front ends, stimulation circuits, power management, and wireless telemetry (RF and inductive coupling)
Deep knowledge of implant power and safety considerations
Familiarity with closed-loop control systems and physiological signal acquisition
Experience operating within a quality system supporting Class III systems
Proficient in analog/digital mixed-signal design tools (e.g., SPICE, Altium, Cadence)
Strong understanding of embedded systems interfaces (SPI, I²C, UART)
Experience with simulation, modeling, and reliability analysis (Monte Carlo, tolerance analysis)
Knowledge of relevant standards: ISO 14708, IEC 60601, ISO 14971, ISO 13485, FDA Class III design controls

Job Responsibility

Develop circuit-level designs for ultra-low-power analog front ends, stimulation drivers, power management, and telemetry interfaces
Define and maintain electrical requirements, design specifications, and interface documents
Lead the design of production test equipment and processes
Perform schematic capture, circuit simulation, component selection, and PCB layout guidance for implantable and external system electronics
Collaborate with firmware and algorithm teams to enable closed-loop control of stimulation based on sensed physiological signals
Drive prototype development, bench testing, and design characterization for implantable hardware
Provide technical leadership to multidisciplinary design teams and mentor junior engineers
Champion design best practices, design for reliability (DfR), and design for manufacturability (DfM)
Driving verification and validation (V&V) activities, including unit, integration, and system-level testing to ensure reliability and traceability
Lead design verification testing (DVT) and verification planning to ensure compliance with medical device standards and safety requirements

Fulltime

Senior Electronics Engineer

As Senior Electronics Engineer, you’ll be responsible for whole-lifecycle design...

Location

United Kingdom , Warwick

Salary:

55000.00 - 60000.00 GBP / Year

Quanta Dialysis Technologies

Expiration Date

Until further notice

Requirements

Degree in Electrical/Electronic Engineering, or a related field
advanced qualifications are a plus
Extensive experience with electronics design in high integrity or safety-critical environments, preferably medical devices although other sectors relevant such will be considered
Strong project management skills, including risk assessment, planning, and execution of complex projects
History of owning and progressing work packages independently

Job Responsibility

Whole-lifecycle design, integration, introduction and sustaining of the electronics on Quanta’s products
Driving technical excellence across complex projects
Mentoring junior engineers
Leading project workstreams
Ensuring successful delivery of solutions that meet regulatory and budgetary requirements
Enhancing the team’s capabilities

What we offer

Bonus

Fulltime

Principal Product Development Engineer

The individual in this role is highly skilled and experienced and can lead and d...

Location

United States , Lake Forest

Salary:

130000.00 - 150000.00 USD / Year

Manufacturing For Design

Expiration Date

Until further notice

Requirements

Bachelor’s Degree in mechanical or biomedical engineering or equivalent experience
7 – 10 years industry experience with a medical device company
Demonstration of excellent communication (written and oral) skills
Demonstration of excellent organizational skills with the ability to adapt to a rapidly changing environments
Prior experience with non-invasive medical devices (catheters)
Ability to present/teach detailed technical information, to all levels of company personnel and customers
Extended periods of sitting
Extended usage of a microscope
Moderate lifting

Job Responsibility

Lead and manage the product development process, from concept through to commercialization, ensuring that projects are delivered on time and within budget
Define product specifications and requirements in collaboration with cross-functional teams
Conduct thorough risk assessments and implement strategies to mitigate potential issues
Collaborate with regulatory affairs and quality assurance team to ensure compliance with all relevant regulations and standards
Collaborate with R&D on the creation of prototypes and conduct experiments to determine validity of designs
Perform and/or manage design verification, equipment qualification and product and process validation
Use CAD software (Solidworks) for part and assembly design and detail drawings
Work closely with manufacturing team to facilitate the transition from development to production
Manage the budget for product development, optimizing costs while maintaining high product quality and compliance
Engage in completing necessary documentations as well as maintaining comprehensive documentation of all product development activities, including design specifications, test results, and regulatory submissions

What we offer

Medical Insurance, Dental Insurance, and Vision Insurance, 100% paid for employee
401K Plan

Fulltime

Principal Engineer, Product Cybersecurity

As Principal Engineer, own and direct the cybersecurity design and analysis of m...

Location

United States , Round Lake; Chicago

Salary:

112000.00 - 154000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

BS in computer science, engineering, mathematics, information management, or related field with 5+ years of industry experience or Masters with 3+ years
Experience with threat modeling, penetration testing, fuzz testing, vulnerability scanning, secure code analysis
Experience with cybersecurity related software such as Blackduck, Coverity, etc.
Experience dealing with threat intelligence, CWEs and CVEs
Familiarity with cybersecurity related organizations and certifications such as UL (UL-2900), ICS-CERT, FIPS 140, etc.
Experience with cybersecurity functionality on embedded systems and hosted software applications
Requires strong organization and communication skills, with the ability to interface with both technical and non-technical personnel
Ability to convince management on courses of action with minimal assistance using both written and verbal methods
Must be able to provide solutions that reflect understanding business objectives.

Job Responsibility

Implement proof of concept project to define innovative solutions on platforms/server platforms
Lead implementation of medical device cybersecurity principles as part of an overall security architecture
Create, own, and maintain system requirements, architectures, risk analysis and other specifications that define the cybersecurity functionality of medical device systems both embedded and hosted
Create threat models of medical device systems and the interfaces between medical devices
Perform vulnerability scanning of medical device systems and analyze results
Monitor threat intelligence and analyze CWEs and CVEs that affect medical device systems and propose solutions
Drive cybersecurity improvements through the cross functional teams, primarily software
Lead discussions to resolve competing constraints between interrelated functions (Engineering, Risk Management, Compliance, Clinical, Human Factors, Regulatory, Marketing, Service)
Ensure compliance to the product development process and Quality System and Design Control requirements
Interface with regulatory bodies, representing Baxter and Baxter products, and ensure that regional cybersecurity needs are met

What we offer

Support for Parents
Continuing Education/Professional Development
Employee Health & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
Medical and dental coverage
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan
Flexible Spending Accounts

Fulltime

Medical Device Engineer Lead

Proclinical

Location:
Belgium , Brussels

Category:
IT - Software Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
May 17, 2026

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