Principal Product Development Engineer

Integra LifeSciences Holdings • Irvine, CA

76d • $125,000 - $170,000

About The Position

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. The Principal Product Development Engineer will lead major system projects of varying scope and complexity across Integra with a focus on neurological diseases. The Principal Product Development Engineer will be responsible for the complete development of the mechanical, electrical, software and optical aspects of a project from feasibility to post commercial launch. The individual will lead a cross-functional project team through all phases of the product development design control process.

Requirements

• 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.

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.

Benefits

• Equal opportunity employer
• Commitment to providing reasonable accommodations for disabled veterans or individuals with disabilities

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Miscellaneous Manufacturing
• Education Level: Master's degree
• Number of Employees: 1,001-5,000 employees