Product Development Engineer II
Listed on 2026-06-20
-
Engineering
Product Engineer, Biomedical Engineer, Medical Device Industry, Quality Engineering
Biomerics is a world‑class manufacturer and innovative polymer solutions provider for the medical device and biotech industries. As a vertically integrated company, we specialize in designing, developing, and producing medical devices for diagnostic and interventional procedures. We are focused on next‑generation solutions for vascular access, electrophysiology, cardiac rhythm management, neurovascular, structural heart, and cardiovascular markets.
Job type:
Full‑time
The NPD Engineer II – Design is responsible for independently executing the design and development of medical devices from concept through commercialization. This role focuses on detailed product design, engineering analysis, and supporting product development activities to deliver high‑quality solutions that meet customer and business needs. This role works closely with customers and cross‑functional teams to develop robust, manufacturable, and compliant designs.
The role demonstrates growing technical expertise, ownership of defined design work streams, and the ability to contribute to complex product development efforts with minimal supervision.
- Supports design and development activities across the product lifecycle, including concept, design, and verification/validation phases.
- Assists in translating customer requirements into engineering specifications and design inputs.
- Contributes to component and sub‑system design efforts under guidance from Senior Engineers.
- Supports development of designs that meet performance, reliability, and regulatory requirements.
- Supports design for manufacturability (DFM) and design for assembly (DFA) efforts.
- Assists in execution of design control processes, including documentation, risk management activities, and verification/validation testing.
- Participates in identifying technical risks and contributes to mitigation activities.
- Assists with engineering change documentation and implementation.
- Supports execution of experiments, testing, and analysis to evaluate product performance.
- Applies fundamental engineering principles to solve defined technical problems with guidance.
- Uses basic analytical and statistical tools to support design decisions and data evaluation.
- Assists in evaluation of materials, components, and design options.
- Works with cross‑functional teams including engineering, manufacturing, quality, and regulatory to support product development and transfer activities.
- Participates in design reviews and team discussions.
- Contributes to assigned tasks and project deliverables with guidance from Senior Engineers.
- Supports documentation, reporting, and project timelines.
- Assists technicians and participates in prototyping and testing activities.
- Builds technical knowledge and skills through hands‑on experience and mentorship.
- Provides input into quotes to ensure accuracy and quick turnaround.
- Performs other duties as assigned in support of business and organizational objectives.
- Bachelor’s degree in Engineering
- Six Sigma Green/Black Belt (preferred)
- 2–5 years of medical device design experience
- Working knowledge of design controls, product development, and verification/validation methods
- Proficiency in 3D CAD (Solid Works preferred) and familiarity with GD&T/drafting
- Experience with analytical and statistical tools (DOE, tolerance analysis, etc.)
- Experience in regulated environments
- Strong technical writing and documentation skills
- Effective communication and collaboration skills
- Demonstrated ability to work independently and own defined design tasks or work streams
- Ability to support and guide technicians or junior team members
Medical/Dental/Vision Insurance, Short‑Term Disability, Long‑Term Disability, Life Insurance, Paid Vacation Days, Paid Holidays, 401(k).
The salary estimates are estimates from this job board and are not a guarantee of Biomerics' salary range.
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