Job Summary:
We are seeking an initiative-taking and energetic Senior Development Engineer. The Sr. Engineer will have the opportunity to directly contribute to the growth of multiple business segments including medical endoscopes, industrial videoscopes, and medical contract manufacturing. This will be done through the development of new products as well as by executing on cost and scrap reduction programs.
Responsibilities:
· Participate in all elements of the product development process including compiling design inputs, documenting design requirements, design for manufacturing evaluations, pilot build and product release readiness, process optimization and cost reduction.
· Leverage external partners as necessary to achieve project objectives.
· Create and maintain product and system documentation to meet internal and external customer needs.
· Work closely with manufacturing and operations to identify and evaluate manufacturing methodologies, assess process capabilities, and prioritize process improvement opportunities to improve quality and reliability and to reduce manufacturing costs.
· Trains and/or provides direction to manufacturing personnel when required.
· Actively collaborates with Quality, Operations, Manufacturing, Sales, and Marketing to execute product development plans.
· Produce clear and accurate technical documentation to promote quality and efficiency in day-to-day work.
· Work closely with and establish critical suppliers. Provide technical support to establish new components, meet critical quality parameters and stay on time with development and production schedules.
· Author verification and validation protocols and reports, executes test plans and employs statistical techniques to establish sampling plans and acceptance criteria.
· Work with accredited test houses to perform assurance testing, inspection, and certification for new and existing products.
Requirements:
· BS in Mechanical, Electrical, Biomedical Engineering or similar.
· Minimum 5 years of work experience in medical devices or related field.
· Direct experience in product or process development
· Must be able to work independently to solve complex technical challenges and make timely decisions.
· Demonstrated commitment to quality through good documentation practices.
· Must be able to communicate effectively in both verbal and written form.
· Comfortable presenting information to team members and stakeholders.
· Must be a US citizen or permanent resident.
Preferences:
· Experience with electromechanical systems.
· Knowledge of common manufacturing methodologies, technologies, and materials employed in medical devices.
· Experience working in a GMP environment.
· Reusable medical device development experience.
· Experience with verification and validation testing of medical devices.
· Ability to work effectively executing on multiple workstreams in parallel.
· Familiar with PLMs and ERP systems.
· Proficiency in problem analysis and problem resolution (8D, PFMEA, 5 Why’s, etc).
· Experience with ISO 13485, CFR 820, MDR
· Proficiency in creating and maintaining Device Master Records, Technical files, and Design History Files.
This position offers a competitive salary commensurate with experience. Join us in a dynamic work environment where your skills will be valued and your contributions recognized.
Job Type: Full-time
Pay: $100,000.00 - $125,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Schedule:
Ability to Relocate:
- Sturbridge, MA 01566: Relocate before starting work (Required)
Work Location: In person