Product Development Engineer, Single-Use Medical Devices

Instant Systems Inc; Norfolk (VA); On-site; USD 80,000 - 115,000; Full time

Benefits offered by this job

401K

Health Benefits: Medical, Dental, Vis

Wellness Program

Life Insurance

Corporate Sponsored Events

Skill growth opportunities

Short Term Disability

Ability to Advance

Energetic problem solvers

Job summary

Instant Systems seeks a Product Development Engineer (PDE) to design, develop and launch new single-use medical and bioprocessing products from customer need to validated, manufacturable design under design controls.

You will own design inputs/outputs, select materials, verify/validate, manage risk, and support transfers to manufacturing. Candidates should have hands-on CAD, testing, and documentation experience in FDA/ISO environments.

Qualifications

• Bachelor's degree in Mechanical, Biomedical, Chemical, Plastics/Polymer or Materials Engineering or closely related field.
• 3–6 years of product development experience in medical devices or FDA/ISO-regulated industry.
• Hands-on experience taking at least one product from concept through launch under design controls.

Responsibilities

• Lead the design of new single-use products and assemblies.
• Create 3D CAD models, drawings with GD&T, and BOMs in SolidWorks or equivalent.
• Build and test prototypes and run design iterations with labs and suppliers.
• Design for manufacturability and sterilization in collaboration with Manufacturing.
• Lead design reviews and transfer designs to Production with complete documentation.
• Manage risk per ISO 14971 and maintain DHF content.

Skills

Independent working

LEAN mindset

Problem solving

Communication

Education

Bachelor's degree in Mechanical, Biomedical, Chemical, Plastics/Polymer or Materials Engineering

Tools

SolidWorks

GD&T

Minitab/JMP

Microsoft Office

Job description

Instant Systems seeks a Product Development Engineer (PDE) to design, develop and launch new single-use medical and bioprocessing products from customer need to validated, manufacturable design under design controls.

You will own design inputs/outputs, select materials, verify/validate, manage risk, and support transfers to manufacturing. Candidates should have hands-on CAD, testing, and documentation experience in FDA/ISO environments.