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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.

Primary responsibilities are to:

+ 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.

Qualifications:

+ 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

Integra LifeSciences 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.

This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:

EEO Is the Law (https://www.eeoc.gov) | EOE including Disability/Protected Veterans (https://www.eeoc.gov/eeoc/publications/ada\_veterans\_employers.cfm)

Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) . If you have difficulty using our online system due to a disability and need an accommodation, please email us at [email protected].

Unsolicited Agency Submission

Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate's name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.

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