Sr. Design Engineer

Position Summary:

The Senior Product Engineering Manager will report directly to senior management and be responsible for leading the development and optimization of oral care medical devices. This role ensures compliance with US FDA 21 CFR 820 Medical Device Design Control requirements and ISO 13485 standards. The position includes full lifecycle support, spanning in-house and contract manufacturing environments for Class I and II medical devices and product packaging.

Key Responsibilities:

• Leadership & Compliance: Lead the product engineering team to ensure adherence to design control processes, including the creation of design inputs, outputs, verification, validation protocols/reports, and design transfer to manufacturing. Ensure that all products comply with FDA regulations and industry standards, actively participating in design reviews and risk assessments.
• Cross-Functional Collaboration: Work closely with cross-functional teams to guide engineering processes and support product development according to established timelines. Lead, mentor, and motivate a team of product engineers, fostering a collaborative and innovative work environment. Provide technical guidance to resolve challenges, and promote best practices to enhance efficiency, quality, and innovation.
• Documentation & Coordination: Manage device drawings and specifications using an electronic document control system to ensure quality and regulatory compliance. Collaborate with the design team to ensure the delivery of high-quality products that meet specifications and standards.
• Sustaining Design Control: Support the assessment of post-market design changes, ensuring that required documentation and actions are completed to implement changes effectively.
• Other Duties: This job description is not exhaustive, and additional duties may be assigned as needed. Responsibilities may change at any time with or without notice.

Education & Qualifications:

• Education: Bachelor’s degree in Engineering (Mechanical, Biomedical, or related field). A Master’s degree is preferred.
• Knowledge & Experience: Minimum of 5 years of Project Development Engineering experience in the Medical Devices industry, specifically with Class I and II medical devices. Experience with a full product life cycle. Deep understanding of FDA regulations and ISO standards for medical devices. Experience with US FDA Unique Device Identification (UDI) requirements is a plus. Experience with statistical software and the creation of sample plans for protocols is desirable.
• Skills & Abilities: Proven leadership skills, with the ability to lead and inspire a team. Exceptional written and verbal communication skills. Proficiency in MS Office (Word, Excel, PowerPoint). Strong interpersonal and organizational skills.

Additional Information:

This position requires a dynamic leader who thrives in a fast-paced environment, navigating both technical challenges and regulatory requirements to bring high-quality medical devices to market. If you're passionate about innovation and compliance in the medical device field, we'd love to hear from you!

• Mid-Senior level

• Contract

• Design and Engineering

• Medical Equipment Manufacturing