Job Summary:
The Principal Development Engineer (PDE) is responsible for the design and development of all mechanical components and systems of the OnPoint Surgical AR guidance system, including surgical instruments and cart. The PDE must possess a complete understanding of all mechanical engineering principles in medical device design and development, including related areas such as electrical safety, electromagnetic compatibility and biocompatibility. Responsibilities include driving product development through the entire lifecycle, hands on execution, as well as team leadership within our growing, dynamic organization. This position reports to the Chief Technology Officer.
Duties & Responsibilities:
- Drive product development through the entire lifecycle, from ideation to launch, through all design control phases, including planning, development, verification/validation and transfer.
- Ensure compliance of product development activities and associated documentation with regulatory requirements, quality standards, and relevant industry guidelines (FDA, ISO, etc.).
- Lead the development and testing of hardware prototypes, including electrical safety tests, usability evaluations and cadaver tests.
- Lead design, development, and/or selection of surgical instruments and components using state of the art mechanical design concepts and materials.
- Develop, design and document products from concept to manufacturing stages.
- Lead or conduct analysis, modeling and experiments to evaluate designs or processes.
- Ensure component reliability based on technical evaluation of vendor designs and manufacturing processes.
- Manage procurement of design and testing prototypes from external vendors and suppliers.
- Drive design and testing process for surgical cart, including assessment of basic safety and essential performance.
- Manage electrical safety and EMC testing certification processes.
- Assist manufacturing suppliers in the transition of design projects from development into production and troubleshooting customer application problems.
- Prepare cost estimates on proposed design products.
- Utilize project planning and monitoring methods to ensure timely completion of tasks.
- Perform and lead design verification and validation studies and experiments.
- Work with RA/QA on validations for biocompatibility, cleaning and sterilization.
- Perform tolerance studies and prepare and release component drawings.
- Plan and perform preliminary and engineering verification tests and mechanical analyses.
- Independently complete all design control product development and documentation tasks including writing and/or verifying specifications; maintaining product and process documentation; creating design failure modes and effects analyses; testing processes, equipment, raw materials and products; and validating equipment and test methods.
- Prepare engineering reports to document and communicate results.
- Perform other related engineering duties as assigned.
- Mentor and develop engineering staff.
Experience and Qualifications:
- Minimum of a Bachelor’s of Science Degree in Mechanical Engineering (Master’s preferred) with 10 or more years applicable mechanical engineering experience.
- Previous experience with spinal medical devices, including instruments and navigation preferred.
- Candidate must possess a strong understanding of mechanical engineering design principles and practices as well as applicable manufacturing processes and materials in a medical device environment.
- 3D solid modeling proficiency required. SolidWorks experience strongly preferred.
- Experience with packaging/sterility, and other advanced manufacturing processes (e.g., welding/bonding) is beneficial.
- Previous experience with commercialization of a medical device.
- Previous experience with 510(k) clearance with the FDA.
- Previous experience with IEC 60601-1, IEC 60601-1-2 and ISO 10993-1.
- Strong working knowledge of US medical device regulations and standards, including 21 CFR 820 and ISO 13485.
- Experience in identifying, onboarding and collaborating with external vendors and suppliers.
- Experience with biocompatibility and sterilization validation studies.
- Experience with disposable medical device design and assemblies.
- Strong communication and teamwork skills including written, verbal, interpersonal and presentation skills.
- Detail-oriented problem solving and analytical skills.
- Ability to multi-task in a fast-paced environment.
- Ability to solve practical problems and deal with a variety of changing situations.
- Self-motivated.
The position is based in Bedford, MA
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