Senior Mechanical Engineer (Biotech Instrumentation)- Gaithersburg, MD

Zachary Piper Solutions; Gaithersburg (MD); On-site; USD 116,000 - 175,000; Full time

Benefits offered by this job

Comprehensive medical, dental, and vision benefits

401(k) and PTO

Performance-based bonus

Job summary

Zachary Piper Solutions is looking for a Senior Mechanical Engineer specializing in Biotech Instrumentation to join a biomedical manufacturing company in Gaithersburg, MD. The role involves leading the design and development of precision instrumentation and requires extensive mechanical engineering experience, particularly in regulated environments.

The successful candidate will collaborate with multidisciplinary teams, ensuring compliance with ISO and FDA standards while engaging in hands-on prototyping and testing.

Qualifications

• 12–15+ years of professional mechanical engineering experience as an independent contributor.
• Proven experience bringing hardware products from concept to mass production.
• Hands-on experience with prototyping, testing, and system integration.

Responsibilities

• Lead end-to-end design and development of precision instruments.
• Collaborate with cross-functional teams to integrate complex subsystems.
• Ensure compliance with ISO, FDA cGMP standards.

Skills

Mechanical design

Electromechanical systems

Instrumentation development

Prototyping and testing

SolidWorks proficiency

ISO/FDA regulated experience

Education

Bachelor’s degree in Mechanical Engineering

Master’s degree (preferred)

Tools

CAD tools

Engineering analysis tools

Job description

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.