Associate Product Development Engineer

Centinel Spine, LLC•West Chester, PA

12h•Onsite

About The Position

Centinel Spine®, LLC is the leading global medical device company exclusively focused on addressing cervical and lumbar spinal disease with prodisc®, the most complete total disc replacement (TDR) technology platform in the world. The Company’s prodisc® technology is the most studied and clinically proven TDR system across the globe, validated by over 540 published papers and more than 300,000 implantations. Centinel Spine’s prodisc® is the only TDR technology with multiple motion-preserving anatomic solutions, allowing the surgeon to Match-the-Disc™ to each patient’s anatomy for both cervical and lumbar total disc replacement. If you are passionate about developing innovative medical devices, we are seeking an Associate Product Development Engineer to support new product development and sustaining engineering activities. In this role, you will contribute to the design, verification, and validation of spinal implants and instruments; support documentation and quality system requirements; and collaborate with cross-functional teams and surgeon advisors to translate clinical needs into effective product solutions. This role reports to the Group Manager, Product Development.

Requirements

Bachelors of Science in Biomedical Engineering, Mechanical Engineering, or equivalent required.
Experience in product development of medical devices and associated components for 1-2 years.
Experience in Mechanical Computer Aid Design (CAD) of components and assemblies.

Nice To Haves

Spine or orthopedics experience preferred.
SolidWorks experience is preferred.
Knowledge of biomechanics and skeletal anatomy is preferred.

Responsibilities

Design new implants and instruments or modify existing medical devices.
Collaborate with cross-functional teams and surgeon advisors to identify clinical needs, define design inputs, and develop innovative solutions.
Utilize internal 3D printing to produce and evaluate CAD models and create complete 2D fabrication and finishing drawings for prototypes and final products.
Verify and validate new designs and design changes, including risk assessment.
Conduct testing and evaluate performance in cadaver labs for new and modified products.
Author, review, approve, and implement verification and validation protocols, as well as feasibility, verification, and validation reports.
Maintain Design History Files (DHFs) in accordance with Centinel SOP 7-10.
Complete DHF outlines and related documentation, track document release status, and support execution of product design plans.
Develop and review design changes and Change Notices (CNs).
Create new and revised documents through the CN system and ensure CAD models are stored correctly within the vault.
Assist Quality in activities such as production inspection, gauging, complaint investigations, non-conformance evaluations, field return assessments, and other QMS/regulatory requirements.
Inspect, evaluate, and test incoming prototypes and first-lot production parts.
Generate and maintain inspection documentation for prototypes and initial production runs.
Communicate clearly and professionally with management and coworkers while maintaining a positive attitude.
Work diligently, reliably, and in a timely manner to meet business needs and project deadlines.
Maintain a professional appearance and demeanor, especially during offsite representation of Centinel and interactions with surgeons.
Ensure compliance with applicable regulations (e.g., QSR, CMDR, MDD), standards (e.g., ISO 13485), and all requirements of the Centinel Spine Quality Management System.