Product Development Engineer

Instant Systems•Norfolk, VA

About The Position

The Product Development Engineer (PDE) designs, develops and launches new single-use medical and bioprocessing products, taking them from customer need to validated, manufacturable design under design controls. The role owns design inputs and outputs, material selection, verification and validation testing, risk management and transfer to manufacturing. It also supports existing products through design changes, cost reduction and customer-driven custom assemblies.

Requirements

Bachelor's degree in Mechanical, Biomedical, Chemical, Plastics/Polymer or Materials Engineering, or a closely related field.
3–6 years of product development experience in medical devices, bioprocessing, pharmaceutical packaging or another FDA/ISO-regulated industry.
hands-on experience taking at least one product from concept through launch under design controls (ISO 13485 / 21 CFR Part 820).
working knowledge of ISO 14971 risk management, including design FMEA.
proficiency in 3D CAD (SolidWorks preferred) and engineering drawings with GD&T per ASME Y14.5.
experience writing and executing verification protocols and reports with statistically justified sample sizes.
working knowledge of polymer materials and plastics joining or forming processes (e.g., RF/impulse welding, heat sealing, extrusion, injection molding, overmolding).
proficiency with Microsoft Office and a statistics package (e.g., Minitab or JMP).
clear technical writing and ability to present to customers and leadership
solid company-centric ideology.
creative problem-solving skills.
the ability to balance multiple priorities.
core values of honesty and respect.
a thirst for learning.
the desire to be challenged.

Nice To Haves

enjoy an autonomous work environment.
have a LEAN mindset.
are the first person to help.
seek out opportunities to bring added value.

Responsibilities

Lead the design of new single-use products: 2D/3D bioprocess bags, tubing and manifold assemblies, aseptic connectors, sampling systems, filter assemblies and custom fluid-transfer sets.
Turn customer, market and user needs into clear design inputs and product specifications.
Create 3D CAD models, drawings (with GD&T) and bills of materials in SolidWorks or an equivalent CAD/PDM system.
Build and test prototypes; run design iterations with the lab, model shop and suppliers.
Design for manufacturability, assembly and sterilization (DFM/DFA), working with Manufacturing and Process Engineering from concept onward.
Execute projects under design controls per ISO 13485:2016 Clause 7.3 and FDA 21 CFR Part 820 (Quality Management System Regulation).
Create and maintain Design History File (DHF) content: design and development plans, design inputs/outputs, traceability matrices, design review records and design transfer documentation.
Prepare and lead design reviews at each phase gate.
Author and revise specifications, drawings, test methods and engineering change orders (ECOs) through change control.
Select polymers and components (e.g., polyethylene and EVA films, silicone, TPE and PVC tubing, polycarbonate, polypropylene) for strength, flexibility, clarity, gas barrier and chemical compatibility.
Define and manage biocompatibility testing per ISO 10993 series and USP <87>/<88> Class VI.
Plan extractables and leachables (E&L) studies, including USP <665> and BPOG-style protocols for bioprocess components, with Quality and external labs.
Specify sterilization method and dose (gamma or e-beam per ISO 11137, EtO per ISO 11135) and support sterilization validation and material aging after irradiation.
Support supplier qualification and material change notifications for critical materials.
Write and execute verification protocols and reports: burst and pressure testing, leak and integrity testing (pressure decay, helium), tensile and seal-strength testing, particulate, connector and weld performance, and shipping/transit testing (ASTM D4169 / ISTA).
Design and support packaging validation per ISO 11607-1 and -2, including accelerated aging per ASTM F1980.
Support design validation with customers and end users.
Apply statistics (sample-size justification, capability, DOE, tolerance analysis) to set test plans and acceptance criteria.
Lead risk management activities per ISO 14971:2019: hazard analysis, design and process FMEAs, and risk control verification.
Keep risk files current through the product life cycle, including post-market inputs.
Transfer designs to Production with complete drawings, BOMs, work instructions, inspection criteria and trained operators.
Support process validation (IQ/OQ/PQ) for welding, sealing, assembly and test equipment with Process Engineering.
Resolve pilot-build and early-production issues, and hand off to sustaining engineering.
Work with Sales and Customer Service on custom single-use assembly requests: review requirements, propose designs and quote engineering feasibility.
Prepare technical content for customer validation packages and regulatory support files (e.g., drawings, material lists, biocompatibility and E&L summaries).
Represent R&D in customer audits and technical meetings.
Investigate complaints, NCRs and CAPAs with a design root cause, and implement design fixes.
Lead cost-reduction, supplier second-sourcing and design improvement projects under change control.
Track new materials, connector technologies and industry standards (e.g., ASTM E3051 for single-use systems) and recommend adoption.
Other Responsibilities As assigned