Medical Device Engineer 3

Actalent is seeking a Senior Medical Device Engineer to develop and optimize polymer-based membrane coatings for advanced biosensor products in a regulated medical device environment.

About the role

This position combines hands-on laboratory work with detailed technical documentation to support product design, process development, qualification, validation, and commercialization. The role is based in an onsite R&D laboratory in San Diego, CA, with a typical split of 50% laboratory experimentation and 50% technical documentation.

Responsibilities

• Develop and optimize polymer-based membrane coatings and related material formulations for advanced biosensor products.
• Plan and perform hands-on wet-lab experiments involving polymers, coatings, chemistry, and materials development.
• Analyze experimental data, interpret results, and make sound engineering decisions to guide product and process development.
• Support design controls by contributing to design inputs, verification, validation, and design transfer activities.
• Participate in risk management activities, including identification, analysis, and mitigation of product and process risks.
• Support qualification and validation activities, including IQ/OQ/PQ, for materials, processes, and equipment.
• Generate high-quality technical documentation, including protocols, reports, standard operating procedures (SOPs), work instructions, and design control deliverables.
• Apply statistical and experimental design tools such as DOE and JMP to plan experiments and evaluate results.
• Collaborate closely with cross-functional teams including R&D, Quality, Manufacturing, Regulatory Affairs, and Process Development to advance products through the development pipeline.
• Ensure work complies with FDA, ISO, GxP, and other relevant regulatory and quality requirements.
• Contribute to continuous improvement of materials, processes, and documentation to enhance product performance and reliability.
• Communicate findings, project status, and technical recommendations clearly to scientists, engineers, and leadership stakeholders.

Requirements

• 5+ years of experience in medical device, biotech, semiconductor, pharmaceutical, or other regulated industries.
• Hands-on experience developing polymer-based materials, coatings, formulations, or related chemical systems in a regulated environment.
• Strong laboratory skills in wet chemistry, material development, and formulation optimization.
• Experience designing products or components within regulated environments.
• Experience supporting design controls and risk management activities.
• Experience with qualification and validation activities, including IQ/OQ/PQ.
• Comfort generating technical documentation such as protocols, reports, SOPs, work instructions, and design control deliverables.
• Experience working within FDA, ISO, or GxP environments.
• Ability to interpret experimental data and make informed engineering decisions.
• Strong technical writing and documentation skills.
• Strong communication and presentation skills.
• Ability to work effectively in a cross-functional team environment.

Qualifications

• Bachelor's degree in Materials Science, Polymer Science, Chemical Engineering, Chemistry, Biomedical Engineering, or a related field.
• Experience with design of experiments (DOE) and statistical analysis tools such as JMP.
• Experience with materials, polymers, chemistry, coatings, enzymes, or related technologies.
• Familiarity with product development processes in medical device or similar regulated industries.
• Interest in advanced biosensor technology and next-generation materials science.
• Desire to work in a highly innovative R&D environment and collaborate with senior scientists, engineers, and technical leaders.
• Motivation to support products as they move through the development pipeline toward commercialization.

Work Environment

This role operates in a professional laboratory and office setting under FDA, ISO, and GxP requirements, with a strong emphasis on quality, documentation, and compliance. Standard business hours are Monday through Friday, approximately 8:00 AM to 5:00 PM.

Pay

The pay range for this position is $56.00 - $68.00/hr. Individual compensation offered within this range will depend on qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Benefits

If eligible, benefits for this temporary role may include:

• Medical, dental, and vision insurance
• Critical Illness, Accident, and Hospital coverage
• 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)

Schedule

This is a contract position based in San Diego, CA, with standard business hours Monday through Friday, approximately 8:00 AM to 5:00 PM.