Centinel Spine · 1 month ago
Associate Product Development Engineer
West Chester, Pennsylvania
Full-time
Onsite
Entry Level
1+ years expCentinel Spine, LLC is the leading global medical device company focused on addressing spinal disease. They are seeking an Associate Product Development Engineer to support new product development and sustaining engineering activities, contributing to the design, verification, and validation of spinal implants and instruments.
Health CareManufacturingMedicalMedical Device
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 (DHF) 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 (CN). 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
Qualification
Required
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
Preferred
Spine or orthopedics experience preferred
SolidWorks experience is preferred
Knowledge of biomechanics and skeletal anatomy is preferred
Company
Centinel Spine
Centinel Spine is a medical device company specializing in treatments for cervical and lumbar spinal diseases.
51-200 employees
H1B Sponsorship
Centinel Spine 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
2024 (1)
2021 (1)
Funding
Current Stage
Growth StageTotal Funding
$100.5MKey Investors
SLR Capital Partners
2025-02-26Debt Financing· $60M
2023-09-07Acquired
2020-03-31Series Unknown· $40.5M
Leadership Team
Steven Murray
CEO
V
Varun Gandhi
Chief Financial Officer
Recent News
Company data provided by crunchbase