Sr Medical Device Engineer

Actalent is seeking a Senior Medical Device Engineer to support the development and scale-up of innovative medical device manufacturing processes and equipment from concept through pilot manufacturing and into full-scale production.

About the role

In this role, you will design and optimize equipment, fixtures, assembly processes, and operating procedures within a regulated quality system, ensuring robust, scalable, and compliant manufacturing solutions. You will 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.

Requirements

• 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 SolidWorks.
• 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, or manufacturing development.
• Experience supporting high-volume manufacturing processes.
• Experience releasing equipment specifications and engineering drawings.
• Experience developing calibration and preventative maintenance programs for manufacturing equipment.
• Experience training operators and manufacturing personnel on new processes and equipment.
• Ability to translate ambiguous manufacturing challenges into structured, repeatable processes.
• Experience supporting R&D, pilot manufacturing, and production scale-up activities.
• Medical device manufacturing experience strongly preferred.

Skills

• Mechanical Engineering, Biomedical Engineering, or Biomechanical Engineering degree preferred.
• Experience with SolidWorks for equipment and fixture design.
• Experience with statistical tools such as JMP and Minitab for DOE, capability analysis, and data interpretation.
• Material characterization and process validation in a regulated environment.
• Familiarity with capability analysis and other statistical methods for monitoring and improving process performance.
• Comfort working in ambiguous environments and defining structure where processes are still evolving.
• Strong collaboration skills for working with engineers, operators, and technicians across R&D and manufacturing.
• Interest in next-generation manufacturing technologies for wearable medical devices.
• Motivation to work in a high-visibility R&D engineering team with contract-to-hire potential.

Work Environment

This is a fully onsite role at an R&D and pilot manufacturing campus in San Diego, working standard business hours (8:30 AM–5:30 PM) with occasional overtime based on business needs. You will operate in a regulated medical device development and manufacturing environment, with a combination of laboratory work, pilot production activities, equipment development, testing, and data analysis. The role is highly hands-on, supporting process development, equipment development, and manufacturing scale-up activities.

You will collaborate daily with a growing team of approximately 4–5 engineers, as well as process engineers, mechanical engineers, technicians, and operators. The environment emphasizes cross-functional teamwork, mentorship, and training of manufacturing personnel, providing broad exposure to product development from concept through pilot manufacturing and into full-scale production.

Schedule

Standard business hours (8:30 AM–5:30 PM) with occasional overtime based on business needs.

Pay

The pay range for this position is $55.00 - $65.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Benefits

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)