FDA design controls jobs

FPGA Team Lead

Kardium Inc. · Posted Nov 13, 2026

Open

Burnaby, British Columbia, Canada
Hybrid
Full-time · Manager
CA$119K–CA$170K per year
5+ years

FPGA Team Lead

Kardium Inc. · Posted Nov 13, 2026

Open

Burnaby, British Columbia, Canada
Hybrid
Full-time · Manager
CA$119K–CA$170K per year
5+ years

Project Manager, Medical Device

Medela · Posted Nov 9, 2026

Open

McHenry, Illinois, United States
Hybrid
Full-time · Senior
$105K per year
5+ years

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Lead innovative product development projects from concept through commercialization in a global medical device environment.

Compensation

Starting salary: $105K

Responsibilities

Manage complex medical device development projects from initial concept and business case through design, development, validation, and commercial launch.
Coordinate global project teams across R&D, Engineering, Marketing, Operations, Supply Chain, Quality, and Regulatory Affairs to ensure alignment and successful execution.
Collaborate with internal teams and external development partners across the United States, Switzerland, and China.
Develop and manage project plans, milestones, budgets, resource requirements, deliverables, and launch schedules while maintaining accountability for project performance.
Proactively assess technical challenges, project dependencies, resource constraints, and potential delays. Develop solutions and escalate critical issues.

Requirements

Bachelor's degree in Mechanical Engineering
Bachelor's degree in Electrical Engineering
Bachelor's degree in Systems Engineering
Bachelor's degree in Information Technology
Bachelor's degree in Natural Sciences

Skills

Medical device product development

Senior Systems Engineer

Cognito Therapeutics · Posted Oct 13, 2026

Open

Cambridge, Massachusetts, United States
Hybrid
Full-time · Senior
8+ years

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Lead systems engineering across the Spectris AD product development lifecycle, from requirements definition through commercialization and post-market support.

Responsibilities

Lead systems engineering activities for Spectris AD across the medical device development lifecycle
Owns the definition, development, and delivery of product features and clinical applications
Drives technical risk identification and retirement while ensuring compliance with applicable quality, regulatory, cybersecurity, and safety requirements
Leads cross-functional development teams spanning engineering, clinical, quality, regulatory, product management, manufacturing, service, and commercial organizations
Ensures requirements flow-down and traceability from patient, caregiver, and clinician needs through system, subsystem, and component level specifications

Requirements

BS in engineering, computer science, biomedical engineering, electrical engineering, mechanical engineering, or a related technical discipline
Nice to have: advanced degree
Nice to have: experience with neurotechnology
Nice to have: experience with wearable or home use medical devices
Nice to have: experience with connected device and companion application architectures

Skills

systems engineering

Sr. Engineer – Disposables R&D

Vantive · Posted Oct 21, 2026

Open

Plymouth, Minnesota, United States
Hybrid
Full-time · Senior
$88K–$121K per year
3–5 years

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Supports new product development initiatives for disposable medical devices.

Compensation

The estimated base salary for this position is $88,000 to $121,000 annually.

Responsibilities

Support or lead projects with global cross-functional teams for new disposable products or extensions
Develop user needs and translate them into product requirements
Identify, investigate, and solve engineering problems using risk-based and customer focused approaches and engineering tools
Create, modify, and maintain design history file documentation
Develop and execute test method validations, product testing, and verification/validation activities

Requirements

BS in Mechanical, Plastics, Biomedical Engineering or a related field, MS preferred
Nice to have: Design for Six Sigma (DFSS) training or certification

Skills

CAD PDM enterprise software FDA Design Controls ISO 13485 Quality Management Systems

Principal Engineer

Vantive · Posted Oct 14, 2026

Open

Plymouth, Minnesota, United States
Full-time · Principal
$104K–$156K per year
5+ years

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Lead design and development of product changes within sustaining engineering for disposable medical devices.

Compensation

The estimated base salary for this position is $104,000 to $156,000 annually.

Responsibilities

Schedule, budget, and lead engineering projects with minimal guidance
Serve as the technical expert for design change programs
Identify, investigate, and solve complex engineering problems utilizing risk-based and customer focused approaches and engineering tools
Lead the creation and maintenance of design history files
Coordinate and communicate the efforts of R&D in collaboration with global cross-functional stakeholders

Requirements

BS in Mechanical, Plastics, Biomedical Engineering or a related field, MS preferred

Skills

plastics materials and processing FDA Design Controls ISO 13485 Quality Management Systems CAD design PDM enterprise software

FPGA Team Lead

FPGA Team Lead

Compensation

Responsibilities

Requirements

Skills

Benefits

Project Manager, Medical Device

Compensation

Responsibilities

Requirements

Skills

Senior Systems Engineer

Responsibilities

Requirements

Skills

Sr. Engineer – Disposables R&D

Compensation

Responsibilities

Requirements

Skills

Principal Engineer

Compensation

Responsibilities

Requirements

Skills

Benefits

Benefits

Benefits

Benefits