Senior Design Engineer - Medical Devices (St. Louis, Missouri)
Position Summary:
Our client in St. Louis, Missouri is seeking a Senior Design Engineer - New Product Development- to play a hands-on role in the development, reverse engineering, and commercialization of medical device components and products.
This is an opportunity for an experienced engineer who enjoys solving problems at the workbench and on the shop floor, not simply managing them from a distance. The ideal candidate will have a strong design engineering background, experience with medical device products, and a practical understanding of how products move from concept and development into a repeatable manufacturing process. A key focus of this role will be bridging the gap between design and manufacturing. This includes understanding how a product should be designed, how it can be manufactured efficiently and consistently, identifying challenges during development, and working directly with manufacturing and other functional teams to bring the product into production.
The engineer will be involved throughout the product lifecycle, from concept and reverse engineering through design development, prototyping, testing, design transfer, and commercialization. This role will work closely with Manufacturing, Quality, Supply Chain, Operations, Engineering, Sales teams and External Suppliers to solve technical problems, drive projects forward, and ensure successful transition of new products into manufacturing.
The ideal candidate is a builder and problem solver, someone who can look at an existing component and figure out how it was made, someone who can sit with a machinist, operator, or technician and work through a manufacturing problem, someone who can take a concept from an engineer's drawing and ask, "How are we actually going to make this?"
This person should be comfortable moving between the engineering office, proto@type area, and manufacturing floor and should enjoy being close to the work.
Strong project management skills are important, but this is not a traditional project management role. The successful candidate will be expected to provide technical leadership while remaining deeply involved in the actual engineering and development work. The ideal candidate will have the potential to grow into broader engineering leadership responsibilities over time, but the immediate need is for a strong Senior Engineer who can roll up their sleeves and help build this capability from the ground up.
Success will be demonstrated by the engineer's ability to: Speed to Market, Successfully reverse engineer existing products and components, Move new concepts efficiently from development into manufacturing, Improve the manufacturability and reliability of new and existing designs, Develop practical solutions to complex engineering and manufacturing challenges, Build strong working relationships with Manufacturing, Quality, Supply Chain, and Operations, Lead projects from concept through commercialization while maintaining hands-on technical involvement & Establish repeatable engineering and design-to-manufacturing practices as the organization continues to grow.
Essential Duties & Responsibilities:
Product Development & Design- Lead and execute product development projects from concept through commercialization.
Develop, modify, and improve medical device components and products.
Perform hands-on design engineering, prototyping, testing, troubleshooting, and technical problem solving.
Participate in design reviews and provide technical recommendations based on performance, manufacturability, cost, and quality.
Apply Design for Manufacturability (DFM) principles throughout the development process.
Support product verification, validation, and other activities required to move products toward commercialization.
Translate product concepts and engineering requirements into practical, manufacturable designs.
Reverse Engineering- Perform hands-on reverse engineering of existing medical device components and products.
Disassemble and evaluate products to understand their design, materials, construction, tolerances, and manufacturing methods.
Take measurements and develop drawings, models, specifications, and other engineering documentation.
Identify opportunities to improve existing designs, manufacturing processes, quality, cost, and performance.
Work directly with machining and manufacturing resources to reproduce, modify, and improve components.
Design-to-Manufacturing- Serve as a key engineering resource in moving products from development into manufacturing.
Identify manufacturing challenges early in the design process and develop practical solutions.
Partner with Manufacturing Engineering and Operations to establish effective manufacturing methods and processes.
Support prototyping, tooling, fixtures, machining, assembly, and process development as needed.
Evaluate supplier and manufacturing capabilities to ensure designs can be produced consistently and efficiently.
Troubleshoot issues that arise during the transition from development to production.
Support design transfer and commercialization activities, ensuring engineering requirements are understood and achievable on the manufacturing floor.
Hands-On Engineering & Manufacturing- Work directly with proto@types, components, tooling, and manufacturing equipment.
When appropriate, perform or support machining, fabrication, assembly, and other hands-on activities to evaluate and develop solutions.
Spend time on the manufacturing floor working directly with operators, technicians, engineers, and other stakeholders.
Use practical engineering judgment to identify root causes and develop solutions rather than relying solely on theoretical analysis.
Collaborate with internal and external manufacturing partners to resolve technical challenges.
Cross-Functional Project Leadership- Lead multiple engineering and product development projects from concept through commercialization.
Develop project plans, timelines, milestones, and technical deliverables.
Coordinate activities across Manufacturing, Quality, Supply Chain, Operations, Engineering, Sales teams and External Suppliers
Keep stakeholders accountable to project timelines and deliverables.
Identify technical, schedule, quality, and manufacturing risks and develop mitigation plans.
Communicate project status, technical issues, and recommendations to leadership.
Remove technical and operational roadblocks to keep projects moving forward.
Quality & Regulatory Collaboration- Work closely with Quality and Regulatory teams to ensure development activities meet applicable medical device requirements.
Support design controls, engineering documentation, change orders, risk management, verification, validation, and design transfer activities as required.
Ensure engineering decisions consider product quality, reliability, regulatory requirements, and manufacturability.
Participate in investigations and corrective actions related to product or manufacturing issues.
Continuous Improvement- Identify opportunities to improve existing products, processes, and engineering workflows.
Evaluate opportunities to reduce cost, improve quality, increase manufacturability, and improve product performance.
Apply engineering problem-solving and root-cause analysis to complex technical challenges.
Help establish and improve processes for taking new concepts through development and into manufacturing.
Qualifications:
Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or a related engineering discipline required. Advanced degree is a plus but not required.
Experience:
7+ years of engineering experience, preferably within medical devices or healthcare products.
Experience taking products from concept through development and into manufacturing.
Demonstrated experience with reverse engineering of products or components.
Strong design engineering experience with an understanding of manufacturing processes.
Experience with Design for Manufacturability (DFM) and design transfer.
Experience working cross-functionally with Manufacturing, Quality, Supply Chain, Operations, and/or suppliers.
Experience leading engineering projects and driving deliverables to completion.
Technical Skills:
Strong mechanical/design engineering fundamentals.
Experience with reverse engineering, precision components, machining, prototyping, and manufacturing processes.
Understanding of tolerancing, materials, drawings, specifications, and manufacturing methods.
CAD experience required; experience with relevant 3D CAD systems preferred.
Understanding of DFM/DFA principles.
Familiarity with design controls, verification/validation, risk management, and design transfer within a medical device environment.
Strong problem-solving and root-cause analysis skills.
Ability to understand both the engineering requirements and the practical realities of manufacturing.
More about the company: Client is a medical device company in St. Louis-based company specializing in the design, engineering, prototyping, and manufacturing of high-quality components and assemblies for medical devices and healthcare applications. Serving OEMs and medical innovators, they provide precision-braided shafts, catheter assemblies, extrusions, and delivery systems used in minimally invasive procedures across cardiology, neurology, gastroenterology, orthopedics, and surgery. Operating within FDA-registered and ISO 13485-certified environments, they offer rapid prototyping, process engineering, and quality-controlled manufacturing to ensure compliance and support innovation in critical healthcare technologies. They supply OEMs and device innovators with components such as braided shafts, catheter assemblies, precision extrusions, and specialized delivery systems for minimally invasive surgical devices, with manufacturing capabilities that include high-precision braiding, extrusion, laser processing, thermal forming, injection and insert molding, and advanced assembly. This allows them to deliver complete device subassemblies or critical parts that meet FDA and ISO 13485 standards. Joining them, you'll have a positive impact on patient care and lives through participation in the development and manufacturing of critical medical technology.
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