Sr Engineer Design
About The Position
The Senior Design Engineer leads complex product design initiatives within cross-functional development teams. The role researches, designs, and prototypes innovative medical devices, translates user needs into design specifications, and ensures compliance with regulatory standards. The engineer provides technical expertise, mentors junior engineers, and drives design excellence across the product development lifecycle, contributing to product launches and continuous improvement. The position leads multidisciplinary product development teams, manages multiple projects and development milestones, supports design transfer from R&D to manufacturing, and evaluates existing products using root cause analysis, risk assessments, and feedback. It also contributes to intellectual property strategy and innovation pipelines. Travel of up to 10% for business purposes, both domestic and international, is required.
Requirements
- Bachelor's degree in mechanical engineering, biomedical engineering, electrical engineering, or a related technical field.
- At least 4 years of experience in product design, preferably in a regulated industry such as medical devices.
- Advanced proficiency in SolidWorks or equivalent 3D CAD software, including prototype development, design documentation, and design for manufacturability.
- Experience working within a structured product development process, including exposure to design controls, risk management, and cross-functional collaboration.
- Strong analytical and problem-solving skills, including the ability to troubleshoot complex design and manufacturing issues.
- Effective communication and collaboration skills, with experience working in cross-functional teams.
- Ability to travel up to 10% for domestic and international business purposes.
Nice To Haves
- Certified SolidWorks Professional certification.
- Product design experience in the medical device industry, including development and launch of Class II devices.
- Strong understanding of design controls, risk management such as FMEA, and regulatory documentation such as DHF, DMR, and traceability matrices.
- Experience designing and launching Class II medical devices, including managing development timelines and milestones.
- Recognized contribution to intellectual property.
- Strong working knowledge of medical-device manufacturing processes such as injection molding, machining, and assembly.
- Familiarity with FDA 21 CFR Part 820, ISO 13485, and ISO 14971.
Responsibilities
- Lead product design efforts by developing CAD models, prototypes, and technical documentation that meet design inputs and regulatory requirements.
- Use SolidWorks and other CAD software to produce 3D models, PCB layouts, and design documentation in accordance with internal standards and regulatory requirements.
- Guide collaboration with product management, clinical, regulatory, and quality teams to define user needs and translate them into design specifications.
- Drive design transfer from R&D to manufacturing through validation builds, process development, and troubleshooting.
- Identify novel design concepts and partner with legal to support patent protection and intellectual property strategy.
- Mentor junior engineers and contribute to design reviews, technical excellence, and continuous improvement.
- Integrate human factors and user-centered design principles into product development to improve safety, effectiveness, and user satisfaction.
- Lead multidisciplinary teams in researching, designing, and developing new products and technologies, ensuring designs meet specifications.
- Coordinate project timelines, resources, and priorities to meet development milestones and business objectives.
- Evaluate and improve existing products through root cause analysis, risk assessments, and feedback from users, manufacturers, and post-market surveillance.
- Collaborate with product divisions to identify product opportunities and align design efforts with long-term strategic goals.
Benefits
- Competitive total rewards package
- Continuing education and training
- Health insurance
- Life and disability benefits
- 401(k) contributions
- Paid time off
- Access to the Employee Assistance Program, Employee Resource Groups, and the Employee Service Corp for employees working fewer than 30 hours per week
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What This Job Offers
Job Type
Full-time
Career Level
Senior
