Senior R&D Tech Lead – Medical Devices

Microline Surgical, Inc; Beverly (MA); On-site; USD 120,000 - 190,000; Full time

Job summary

Microline Surgical, Inc. is seeking a Senior Tech-Lead in the R&D department to guide cross-functional teams in designing and developing new medical devices that reduce manufacturing costs and lead times while meeting market needs.

You will own technology and component strategies for new products, drive plans for major project segments, and ensure compliance with ISO, FDA, and design control guidelines. Strong leadership and communication are essential.

Qualifications

• BS or MS in Mechanical or Biomedical Engineering.
• 6–10 years of related experience in the medical device industry.
• 3+ years of Technical Management or Project Leadership experience.
• Experience translating customer needs to product requirements; and developing DHF deliverables like Product-spec, Risk Management, Verification & Validation, etc.
• Knowledge of ISO, FDA, GMP and design control process.
• Proficiency in SolidWorks.
• Experience with DFA (Design for Assembly).

Responsibilities

• Translate customer needs into product requirements and design specifications.
• Lead cross-functional teams to develop new devices from prototype to pilot manufacturing.
• Coordinate, manages, and documents project goals and progress of an R&D team.
• Interface with physicians to obtain feedback on concepts and performance of new devices.
• Ensure compliance with ISO, FDA and design control guidelines throughout development.

Skills

Leadership

Cross-functional collaboration

Medical device development

Design control

Regulatory knowledge

Verification & validation

Education

BS/MS in Mechanical or Biomedical Engineering

Tools

SolidWorks

Job description

Microline Surgical, Inc. is seeking a Senior Tech-Lead in the R&D department to guide cross-functional teams in designing and developing new medical devices that reduce manufacturing costs and lead times while meeting market needs.

You will own technology and component strategies for new products, drive plans for major project segments, and ensure compliance with ISO, FDA, and design control guidelines. Strong leadership and communication are essential.