Medical Device Engineer Job at Boden Group (Coventry)

Sr. Software Engineer (Medical Devices)

Location

United States , Raleigh, NC

Salary:

Not provided

Bytecubit Technologies

Expiration Date

Until further notice

Requirements

7+ years’ experience with SW development
SW development for Medical Devices
BS in Computer Science
C, C#, C++ skills
Microsoft.NET
SQL database
GUI application development
Windows 10
Cryptographic algorithm

Job Responsibility

Consultant will be responsible for design and development of embedded SW for medical device to support manufacturing of products
write SW requirements
provide design input for GUI system SW
design development and implementation of cybersecurity control methods for FDA NIST standards
testing, static analysis, profiling and debugging
take measurements using lab equipment tools
data processing for test protocols

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

Systems Engineer - Spine & Trauma Medical Solution

As (Senior) Systems Engineer, working in the Medical Device Team of Brainlab’s S...

Location

Germany , Munich

Salary:

Not provided

Brainlab

Expiration Date

Until further notice

Requirements

Graduate of a technical or scientific course of study (e.g. mechanical engineering, medical technology, physics, medicine, informatics, ...) or related discipline or equivalent working experience
Several years of professional experience in development in a regulated industry (medical devices preferred)
Natural team player, strong communication and documentation skills and ability to work cross-functionally
Fluent in written and spoken English

Job Responsibility

working in a LeSS environment as part of a cross-functional team, collaborating closely with Product Owners and departments such as Quality Assurance, Usability, and other teams involved in the solutions
working on integration, verification, validation on system (use case) level to bring spinal portfolio solutions into the highly regulated medical device market following MDR and FDA regulations
working with the clinical and regulatory affairs team, e.g. for clinical studies or FDA applications

What we offer

30 vacation days, plus December 24th and December 31st
Flexible working hours
hybrid work model within Germany
Bike leasing via cooperation partner "BikeLeasing"
Parking garage and safe underground bike storage
Award-winning subsidized company restaurant and in-house cafes
Variety-rich fitness program in our ultra-modern 360m2 company gym
Regular after work, team, and company events
Comprehensive training and continuing education opportunities

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

Senior Principal Software Quality Engineer

As a Senior Principal Software Quality Engineer at Baxter, you will play a criti...

Location

United States , Raleigh

Salary:

120000.00 - 165000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

B.S. in Engineering or other technical degree required, preferably Computer Science/Engineering or Electronics/Electrical Engineering
Software Quality experience is highly sought, especially in the medical device industry
Knowledge of AAMI 62304 standard is valuable
Minimum 8 years of experience in medical device or other regulated technical industry (e.g., aerospace, automotive, defense) in a design/development/quality role or in a role closely connected to design/development/quality is required
Proven ability to perform and influence in cross-functional team environments and utilize effective interpersonal skills
2+ years of Quality experience desired
Product Design experience may be considered in lieu of Quality Assurance experience
Software development experience in a regulated industry is desirable
Knowledge of software development lifecycle processes and standards required
Understanding of software development tools and methods for medical devices and/or other regulated industries desirable

Job Responsibility

Responsible for all Design Assurance functions as a core team member on new product development (NPD) teams, ensuring the team complies with all portions of Design Control and related Quality System elements
Prepare and manage all Design Assurance required deliverables as well as support the remainder of the team in developing a quality product that meets regulatory requirements
Responsible for ensuring product development activities related to verification and validation are fully compliant to the quality system procedures
Assist in identification and mitigation of product or process-related risks

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 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)
401(k) Retirement Savings Plan (RSP)
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

Electrical Engineer Student

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

3rd year BSc student in electrical engineering from a well-known establishment
Experience in the medical device industry and with FDA and ISO 13485 medical device regulations - an advantage
Great problem-solving and debugging capabilities
Availability for 24 hours a week
Full control of all Microsoft Office applications
SolidWorks
Fluent English (written and verbal)
Strong technical and analytical skills
excellent interpersonal relationships
self-motivated

Job Responsibility

Resolve the company products technical issues and continuously support and improve the products’ quality
Conduct technical investigations and experiments, drive for root cause identification as a part of the NCMR process
Perform verification and validation activities for the production line

Parttime

Medical Device Engineer

Boden Group

Location:
United Kingdom , Coventry

Category:
IT - Administration

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
February 07, 2026

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Location:United Kingdom , Coventry

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Job Description:

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