Principal Product Development Engineer

Overview

Changing lives. Building Careers.

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.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

• 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.

• 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.

Salary Range: $125,000 - $170,000

Salary Pay Range: $ - $ USD Salary

Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training . In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation . Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).

Integra Life Sciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

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