Product Development Engineer

Appone; 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

About the Organization By joining the Instant Systems team, you will be at the forefront of innovation in med tech and biotechnology. You will work with innovative companies who are leading the way in creating lifesaving therapies for patients around the world. You will work side by side with your fellow team members to create future innovations for best patient outcomes. We are looking for strategic problem solvers who thrive in an autonomous environment of diverse and energized collaborators. If you are motivated by new challenges and opportunities for skills growth, we welcome you to apply. Your energy and expertise is valuable, spend it making a difference on a worthy mission.

Description

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.

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

To be considered you’ll need:

• 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.

You will thrive if you:

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

Company Benefits & Perks

• 401K
• Health Benefits: Medical, Dental, Vision
• Wellness Program
• Life Insurance
• Corporate Sponsored Events
• Skill growth opportunities
• Short Term Disability
• Ability to Advance
• Working with energetic & creative problem solvers
• A mission worthy of your energy and expertise

Applicants for this position must successfully pass background, drug screen and reference check. It is impossible to list every requirement for, or responsibility of, any position. Similarly, we cannot identify all the skills a position may require since job responsibilities and the Company's needs may change over time. Therefore, the above job description is not comprehensive or exhaustive. The Company reserves the right to adjust, add to or eliminate any aspect of the above description. The Company also retains the right to require all employees to undertake additional or different job responsibilities when necessary to meet business needs.

Full-Time/Part-Time Full-Time

Instant Systems’ provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Salary Range $80,000-$115,000

Mechanical Engineer in Norfolk, Virginia
Posted on: 4/17/2026