Principal Design Engineer

Job Summary

Responsible for managing product development teams as well as coordinating all aspects of the design and development of new products and technologies. Provide expertise on product design and optimize design specifications. Lead product design assignments in product development initiatives.

Major Responsibilities

• Manage multi-disciplinary product development teams to research, design, and develop new products and technologies. Ensure that deadlines and product goals are met.
• Collaborate with customers, quality, regulatory, legal, manufacturers, and divisional personnel to ensure new product designs meet all product requirements and experience a successful launch.
• Develop design specifications, manage multiple project timelines, and balance corporate priorities for product development projects to ensure that deadlines and goals are met.
• Collaborate with product divisions to proactively identify product development opportunities, establish innovation pipelines, and align product development efforts with long-term divisional strategies.
• Coordinate and support all phases of product development from ideation to 510k application to product launch.
• Review existing products and recommend improvements based on existing complaints, risk analyses, manufacturer feedback, cost saving opportunities, etc.
• Support design transfer to manufacturing sites and new product implementation process. Collaborate with domestic and international manufacturers to validate designs and troubleshoot problems that arise.
• Coordinate product design and laboratory teams to ensure all design inputs are verified and validated.
• Contribute to new product designs, prototype generation/evaluation, and review technical drawings/specifications.
• Work with legal to design and implement new intellectual property.
• This is a high-level individual contributor role - management responsibilities limited to leading day-to-day activities and outcomes of a group of employees.
• May be involved in hiring staff, recommending pay increases, performing performance reviews, training and development of staff, estimating personnel needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of organizational policies.

Minimum Job Requirements

Education: Bachelor's degree in mechanical engineering, biomedical engineering, electrical engineering, or software engineering

Certification / Licensure: None

Work Experience: At least 7 years of experience in product design. Experience with Solidworks/3D modeling software and prototype fabrication.

Knowledge / Skills / Abilities: None

Preferred Job Requirements

Education: None

Certification / Licensure: Certified Solidworks Professional.

Work Experience: At least 10 years of experience in product design. Experience testing and development of polymers, textiles, medical equipment/devices, etc within in the medical device industry. Experience with medical device requirements (Class I-II), design controls, risk assessments, and the 510k process. Experience designing and launching class II medical device to market. Experience with project management, Microsoft project, and leading multi-disciplinary teams. Invented and recognized on at least one patent.

Knowledge / Skills / Abilities: Position requires travel up to 10% of the time for business purposes (domestic and international). Knowledge of injection molding and other manufacturing processes.