Senior R&D Engineer

A passionate Senior Product Development Engineer will support sustaining engineering initiatives for Class II and III disposable medical devices, driving engineering solutions from concept through implementation in a highly regulated environment.

This role offers the opportunity to work on meaningful products, collaborate with global cross‑functional teams, and contribute to the design and improvement of medical device solutions that improve patient outcomes.

• Lead small to medium‑size projects focused on product improvements, compliance, quality, and performance enhancements, including supplier and material changes, labeling updates, CAPA/NCR activities, cost‑reduction initiatives, and product remediation efforts.
• Identify and solve complex engineering challenges using risk‑based and customer‑focused methodologies.
• Develop and maintain technical documentation, including design specifications, engineering drawings, validation protocols and reports, and product labeling documentation.
• Plan and execute verification & validation (V&V), product testing, and test‑method validations.
• Build prototypes and support fixture / tooling development for product evaluation and manufacturing support.
• Ensure compliance with FDA regulations, ISO standards, design controls, and quality system requirements.

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Plastics Engineering, or a related discipline.
• 3+ years of experience developing or supporting Class II and/or Class III medical devices.
• Experience with disposable medical product design and sustaining engineering activities.

• Plastics processing technologies including injection molding, extrusion, ultrasonic welding, bonding processes, and sterilization methods.
• CAD and Product Data Management (PDM) platforms such as Creo or Solid Works.
• FDA Design Controls and ISO 13485 Quality Management Systems.
• Risk Management practices aligned with ISO 14971.

• Self‑starter with a strong sense of ownership and accountability.
• Innovative mindset with a passion for continuous improvement.
• Strong communication and cross‑functional collaboration skills.
• Highly organized with excellent attention to detail.
• Ability to manage multiple priorities in a fast‑paced environment.

You’ll join a team focused on delivering high‑quality medical device solutions that make a real difference for patients and healthcare providers worldwide. If you enjoy solving complex engineering challenges, driving product improvements, and working in a collaborative environment, we’d love to connect.

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, direct‑hire employees may be eligible for client‑offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.