GeneCapture - Product Development & Manufacturing Process Engineer

COMPANY OVERVIEW

Gene Capture offers a transformative workplace with opportunities for professional growth in an innovative and collaborative environment. We are developing novel platform technologies for rapid, portable, and affordable infection diagnostics at the point of care. You will be joining Gene Capture's flexible team of engineers and scientists with our eyes on the exciting potential of our breakthrough technology. You will be exposed to all stages of the medical product development cycle.

As a product developer, the candidate will directly support daily engineering and manufacturing activities with a focus on supply chain, product assembly, and process scalability. The candidate will work as a member of the Product Design & Development Team responsible for the design of medical, laboratory, and industrial disposable devices. The candidate must be self‑motivated and a great problem‑solver.

• Bachelors of Science in Mechanical Engineering or similar B.S. degree (Associates degree may be considered with relevant experience)

• 3-7+ years industry experience developing medical / laboratory devices
• Development of production test equipment
• 2+ years of experience in a manufacturing environment
• Experience with multiple plastic joining and bonding methods
• Proficiency with Microsoft Office products (Word, Excel, PowerPoint, etc.)
• Product Verification & Validation
• Quality Documentation
• Familiarity with Injection molding and tooling design

• Proficient in technical writing and creating summary reports
• Exposure to Rubber/Polymer Sealing Technologies
• 3D Printing, Rapid Prototyping experience
• Effective communication with people and capable of leading meeting discussions
• A self‑starter and require little oversight to complete given tasks
• Experience working with diverse groups of individuals, including engineers, technicians and scientists
• Diagnostic cartridge design & development
• Familiarity with ISO 13485 and 21 CFR 820 Quality System Requirements
• 3D modeling & 2D drawing experience with Solid Works
• Experience with high volume low cost fluidic disposable products

• Work as part of a team supporting engineers and technicians.
• Work with in-house project staff and outside vendors to optimize design for manufacturability of a point of care disposable diagnostic cartridge.
• Support multiple projects in an environment that changes quickly in response to product learnings.
• Create, maintain and execute test plans and test cases for the products.
• Work in cross‑functional project teams to plan and cost features.
• Design, build and improve test equipment and tools/processes.
• Investigate product issues, provide clear and insightful analysis of root cause, analyze patterns and effectively prioritize failure mode risks.
• Create detailed design and engineering documentation; including engineering drawing, reports and design intent documentation.
• Support project design reviews, ensuring proper material selection, component tolerances, etc.
• New product design, prototyping and testing.
• Test fixture design, prototyping and testing.
• Works with manufacturing and outsourcing vendors concerning questions and problems encountered with drawings.

• Medical Device
• Plastic Joining
• Plastics Manufacturing
• ISO 13485
• 21 CFR 820
• Product Design
• Product Testing
• Technical Writing
• Problem Solving
• Design Control
• Quality Control
• Solid Works

ADA Requirements:
The physical demands, work environment factors, and mental functions described below are representative of those that must be met by an employee to successfully perform the essential function of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Disclaimer:
All job requirements are subject to possible revision to reflect changes in the position requirements or to reasonably accommodate individuals with disabilities. Some requirements may exclude individuals who pose a threat or risk to the health and safety of themselves or other employees. This job…