Product Development Engineer

Product Development Engineer

The Product Development Engineer designs and develops medical devices from initial concept through market release, with a focus on catheter-based technologies. This role combines hands-on mechanical design, process development, and validation activities to ensure products function as intended and meet regulatory requirements. The engineer maintains detailed documentation, performs risk analyses, and collaborates closely with cross-functional teams and external partners in a fast-paced, growing contract manufacturing environment.

Responsibilities:

• Develop new product concepts and drive them from initial design through market release with limited support.
• Design and implement new methodologies, materials, machines, processes, or products to bring concepts to market.
• Create and maintain essential product and process documentation throughout all phases of product development.
• Contribute with minimal oversight to the execution of protocols and reports to support validation activities, including Design Verification.
• Conduct product and process characterization with minimal oversight to confirm that devices function as intended.
• Perform risk analysis for products under development and incorporate risk mitigation strategies into designs and processes.
• Coordinate activities with outside suppliers and consultants to ensure timely delivery of supplies and services needed to meet project timelines.
• Lead or support rapid design iterations and make informed design recommendations based on testing, feedback, and evolving project requirements.
• Independently develop and adapt work plans in response to vague or changing project goals, ensuring progress toward key milestones.
• Use Solid Works 3D CAD to design components and assemblies for catheter-based and related medical device technologies.
• Support Design Verification and Design Validation activities in alignment with design control procedures and applicable regulations.
• Document development work clearly and thoroughly, including technical reports, test plans, test results, and design history records.
• Interact with clients and partner companies in a professional manner, providing technical updates and incorporating feedback into designs.
• Collaborate with R&D, engineering, and manufacturing teams to transition designs into robust, scalable processes.
• Apply knowledge of probability and statistics, and where applicable, use statistical tools such as Minitab to analyze data and support decision-making.

Essential

Skills:

• Bachelor's degree in Mechanical or Biomedical Engineering is desired; in lieu of a degree, relevant experience in a similar or equivalent role will be considered.
• 0–3 years of medical device design and development experience.
• Experience with Design Verification, Design Validation, and design control processes.
• Solid Works 3D CAD proficiency, with the ability to design components and assemblies for mechanical and catheter-based devices.
• Knowledge of human cardiac and cardiovascular anatomy and physiology.
• Experience with catheter development, including C0/C1 catheter design.
• Hands-on approach to mechanical engineering, product development, and process development activities.
• Ability to lead rapid design iteration and make clear, data-driven design recommendations.
• Ability to independently develop and adapt work plans based on vague or changing project goals.
• Familiarity with FDA Quality System Regulation (QSR) and ISO medical device regulations.
• Knowledge of catheter-based technologies, including reinforced shafts, delivery systems, and steerable catheters (preferred).
• Knowledge of probability and statistics, with familiarity in statistical software such as Minitab (preferred).
• Depth of knowledge in one or more technical areas, such as finite element analysis.
• Comfort with technical writing, including preparation of protocols, reports, and other formal documentation.
• Customer-focused mindset with excellent written and oral communication skills.
• Ability to interact professionally with clients and external partners.
• Organized, motivated, and strong sense of ownership over work and deliverables.

Additional Skills &

Qualifications:

• Experience in new product development within medical devices, particularly in R&D and mechanical engineering environments.
• Experience working in a contract manufacturing or similar fast-paced, project-based setting.
• Familiarity with reinforced shaft design, delivery systems, and steerable catheter technologies.
• Experience using statistical analysis tools such as Minitab to support validation and characterization activities.
• Previous experience or interest in finite element analysis or other advanced technical disciplines.
• Demonstrated ability to bring products from concept to market, including participation in all key development phases.
• Strong organizational skills, with the ability to manage multiple tasks and timelines simultaneously.
• Motivated, proactive, and comfortable taking initiative in a collaborative environment.
• Comfortable working hands-on…