Integra LifeSciences · 3 hours ago
Principal Product Development Engineer
Irvine, CA
Full-time
Onsite
Senior Level, Lead/Staff
$125K/yr - $172K/yr
7+ years expIntegra LifeSciences is focused on innovating new treatment pathways to advance patient outcomes in healthcare. The Principal Product Development Engineer will lead complex medical device system projects, overseeing all aspects from feasibility to post-commercial launch, while collaborating with cross-functional teams to ensure compliance and safety of the devices.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
Responsibilities
Lead the design and development of complex medical device systems from concept to commercial
Confirm the usability, safety, and effectiveness of device systems
Collaborate with suppliers and customers
Lead the cross-functional development team
Resolve technical issues by applying theoretical and practical engineering
Coach, mentor, and delegate assignments to project staff members
Analyze data using statistical and engineering techniques
Prepare and review test protocols and reports, drawings, technical specifications, and change orders
Ensure compliance with internal SOPs, Design Control and regulatory requirements
Stay abreast of emerging technologies, competitors, and intellectual property
Identify new and innovative technologies
Qualification
Required
B.S. or equivalent in a scientific discipline with 9 or more years of applied experience; A M.S. with 7 or more years of applied experience; A PhD with 4 or more years of applied experience
Experience developing medical device systems from concept through commercial release
Demonstrated experience developing systems requiring multiple technical disciplines, such as mechanical, electrical, optical and software engineering
Proficiency with computer aided design (CAD) such as Solidworks or Onshape
Expert knowledge of fabrication methods and techniques
Highly proficient applying dimensioning and tolerancing drafting standards (GD&T)
Demonstrated hands-on approach to engineering problem solving
Strong understanding of medical device regulations and industry standards
Demonstrated ability to manage large system projects
Proficiency in statistical data analysis and the ability to utilize appropriate tools, such as Minitab
Expertise in Risk Management (Hazard, Use, Design, and Process FMEA)
Experience collaborating with functional and technical groups to achieve company objectives, such as Operations, Regulatory, Quality, Software, Packaging, Clinical, etc
Excellent technical communication skills, verbal and written
Advanced troubleshooting and problem-solving skills
Able and willing to mentor junior level staff members
Benefits
Medical
Dental
Vision
Life insurance
Short- and long-term disability
Business accident insurance
Group legal insurance
Savings plan (401(k))
Company
Integra LifeSciences
Integra LifeSciences is an integrated medical device company.
1001-5000 employees
H1B Sponsorship
Integra LifeSciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (5)
2023 (4)
2022 (7)
2021 (5)
2020 (4)
Funding
Current Stage
Public CompanyTotal Funding
$350M2018-05-15Post Ipo Equity· $350M
1995-08-25IPO
Leadership Team
Mojdeh Poul
Chief Executive Officer
Lea Knight
EVP and Chief Financial Officer
Recent News
Integra LifeSciences Holdings Corporation
2025-12-02
Medical Product Outsourcing
2025-11-13
Company data provided by crunchbase