Unknown Company
Senior Mechanical Engineer (Biotech Instrumentation)
Zachary Piper Solutions is seeking a Senior Mechanical Engineer (Biotech Instrumentation) to join a biomedical manufacturing company located in Gaithersburg, MD. The position is 100% onsite.
Responsibilities
- Lead end‑to‑end design and development of precision mechanical and electromechanical instrumentation.
- Develop CAD models, engineering drawings, and detailed design documentation using SolidWorks.
- Perform hands‑on prototyping, bench assembly, testing, and troubleshooting of systems.
- Collaborate cross‑functionally with electrical, systems, and bioengineering teams to integrate complex subsystems.
- Drive product lifecycle efforts from early concept through mass production and manufacturing scale‑up.
- Develop requirements, specifications, and validation/test protocols for new products.
- Analyze performance data and generate detailed technical reports and design improvements.
- Provide mentorship and technical leadership within a multidisciplinary engineering team.
- Ensure compliance with ISO, FDA cGMP, and regulated product development standards.
- Support vendor selection, component sourcing, and manufacturing process development.
Qualifications
- 12–15+ years of professional mechanical engineering experience as an independent contributor.
- Strong experience with mechanical design, electromechanical systems, and instrumentation development.
- Background in biotech, life sciences, medical devices, fluid systems, or related industry.
- Proven experience bringing hardware products from concept to mass production.
- Hands‑on experience with prototyping, testing, and system integration.
- Proficiency in CAD tools such as SolidWorks (or similar) and engineering analysis tools.
- Experience working in ISO/FDA regulated environments.
- Knowledge of manufacturing processes including machining, sheet metal, and injection molding.
- Experience with motors, automation systems, or motion control components.
- Bachelor’s degree in Mechanical Engineering (Master’s preferred).
Nice to Have
- Experience with microfluidics or precision fluid systems.
- Mechatronics or robotics experience.
- Exposure to thermal management systems.
- Consumer product design experience involving moving components.
- Familiarity with automation, pick‑and‑place systems, or end‑of‑arm tooling.
Compensation
- Salary Range: $116,000 – $175,000 depending on experience.
- Comprehensive benefits include medical, dental, vision, 401(k), PTO, sick leave (as required by law), and holidays.
- Annual raises (3–4%) and performance‑based bonus (typically 4–6%, up to 10%).
- Clearance level: Must be eligible to work in the United States (no sponsorship available).
- Location: 100% onsite in Gaithersburg, MD.