R&D Engineer Role Summary
The Research and Development Engineer is responsible for:
- Leading and executing product and process development projects within the R&D/Operations group
- Driving initiatives from concept through implementation
- Responsible for defining project strategies, coordinating testing and ensuring timely completion of programs in alignment with Company milestones.
- Collaborate cross-functionally to ensure that all R&D activities support departmental and Company objectives while providing technical expertise, guidance to team members and contributing to innovation in production development.
*
Essential functions and responsibilities:
- Leads and drives the execution of complex product and process development programs, ensuring alignment with strategic objectives and Company milestones.
- Provides expert technical guidance and direction to team members, assembly personnel, and external consultants engaged in R&D/OPS initiatives.
- Independently plans, oversees, and reports on design verification and validation testing, ensuring programs are executed in full compliance with design control guidelines and delivers results within established timelines.
- Plays a key role in establishing and optimizing relationships with contract manufacturing suppliers to support scalable and reliable production.
- Develops precise CAD solid models and drawings, including advanced dimensioning and tolerancing, and ensures the accuracy, completeness, and regulatory compliance of all technical documentation.
- Collaborate cross-functionally to identify project priorities, coordinate efforts across departments and resolve complex technical or process challenges, providing strategic recommendations that drive innovation, efficiency and the successful advancement of ophthalmology product development programs.
- Take ownership of a high-level project, device or fixture.
- Execute projects with little supervision.
- Lead design reviews with cross-functional departments (R&D, QA, OPS)
- Lead the documentation of project-level information.
- Mentor interns, technicians, and junior engineers.
- Familiarity with the variety of materials and manufacturing processes common to medical devices.
- Possess good working knowledge of ophthalmic devices and of cross-functional, regulatory and business needs.
- Interface effectively with internal and external teams (i.e., suppliers, consultants, service providers, contract manufacturers, test labs, customers, sales reps, physicians, etc.)
- Develop detailed, realistic overall program schedules and adhere to them, driving other functional areas as required for program success.
Role receives direction from:
Role provides direction to:
Qualifications:
- Bachelors in engineering or related field.
- Minimum five years’ engineering experience.
- Experience working in a regulated medical device environment is preferred.
- Basic familiarity with 510(k) and MDR regulatory requirements.
- SolidWorks/Cad experience
- Deep understanding of medical device regulations (FDA 21 CFR Part 820, ISO 13485.
- Strong written and verbal communication skills.
- Supervisory and motivational skills required.
- Ability to identify problems and take corrective measures to solve them quickly and efficiently
- Travel – as needed
- Physical requirements: standing, sitting, walking, stairs, light lifting, manual dexterity, operating computers. Ability to tolerate direct exposure to IPA, adhesives, part cleaning solutions and other materials common to medical device production.
Job Types: Full-time, Permanent
Pay: $85,000.00 - $95,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Vision insurance
Work Location: In person
