Sr Medical Device Engineer

Job Title:

Senior Medical Device Engineer

Job Description

The Senior Medical Device Engineer supports the development and scale-up of innovative medical device manufacturing processes and equipment from concept through pilot manufacturing and into full-scale production. In this role, you design and optimize equipment, fixtures, assembly processes, and operating procedures within a regulated quality system, ensuring robust, scalable, and compliant manufacturing solutions. You work closely with R&D and Pilot Manufacturing teams to implement new technologies and processes that directly influence how future wearable medical devices are built.

Responsibilities

+ Lead process development activities from early concept through pilot manufacturing and production scale-up.

+ Design and optimize manufacturing equipment, fixtures, assembly processes, and operating procedures within a regulated quality system.

+ Perform process characterization and execute design of experiments (DOE) to understand and optimize critical process parameters.

+ Conduct material qualification activities to ensure materials meet performance and regulatory requirements.

+ Lead root cause investigations to resolve process and equipment issues and implement effective corrective actions.

+ Provide technical oversight of pilot production builds, ensuring processes, equipment, and documentation are properly implemented.

+ Drive risk mitigation efforts related to new equipment, processes, and manufacturing technologies.

+ Validate equipment performance and support process validation activities for medical device manufacturing.

+ Manage engineering projects and timelines independently, ensuring milestones and deliverables are met.

+ Transfer technologies from development to manufacturing, including R&D, pilot manufacturing, and production scale-up activities.

+ Release equipment specifications and engineering drawings to support manufacturing and maintenance teams.

+ Develop calibration and preventative maintenance programs for manufacturing equipment and fixtures.

+ Train operators, technicians, and manufacturing personnel on new equipment, processes, and procedures.

+ Turn ambiguous manufacturing challenges into structured, well-defined processes and documentation.

+ Support high-volume manufacturing processes and continuous process improvements as needed.

+ Collaborate cross-functionally with process engineers, mechanical engineers, technicians, and operators in a fast-paced environment.

+ Mentor and support manufacturing personnel, fostering strong technical understanding and adherence to best practices.

+ Perform testing, data analysis, and capability analysis to monitor process performance and drive optimization.

+ Contribute to a high-visibility R&D engineering team focused on next-generation manufacturing technologies for wearable medical devices.

Essential Skills

+ Bachelor's degree in Engineering or a related technical discipline.

+ 5-8 years of engineering experience, preferably in process or equipment development.

+ Hands-on experience designing and optimizing manufacturing equipment and fixtures, including use of Solid Works.

+ Demonstrated experience executing design of experiments (DOE) and validating equipment performance.

+ Proven ability to perform root cause investigations and implement process improvements.

+ Experience moving products from R&D through pilot manufacturing and into production scale-up.

+ Ability to independently manage engineering projects, priorities, and timelines.

+ Experience working in regulated development environments, ideally medical device.

+ Strong technical problem-solving and troubleshooting skills in manufacturing and process development settings.

+ Ability to work effectively in ambiguous and fast-paced environments while maintaining high quality standards.

+ Experience transferring technologies from development to manufacturing and supporting scale-up activities.

+ Excellent verbal and written communication skills for cross-functional collaboration and training.

+ Strong attention to detail and organizational skills in documentation and execution.

+ Demonstrated hands-on engineering experience in equipment, process,…