Design Engineering Manager

$110,000 - $120,000/Yr

Std Med - Stoughton, MA

Full-time - Mid Level

Stoughton, MA

Miscellaneous Manufacturing

About the position

The Design Engineering Manager will lead the design and development engineering team for contract manufacturing operations, focusing on medical device projects from concept to production. This role is crucial in ensuring that designs meet client specifications, regulatory standards, and internal quality benchmarks. The ideal candidate will possess a strong engineering background in medical devices and experience in design for manufacturability (DFM) and design for assembly (DFA).

Responsibilities

• Lead, mentor, and develop a team of design engineers to deliver high-quality and innovative medical device solutions.
• Manage project timelines, resources, and budgets for design engineering initiatives, ensuring timely delivery and adherence to specifications.
• Collaborate cross-functionally with Quality, Production, and Regulatory teams to ensure that engineering designs align with manufacturing capabilities and quality standards.
• Oversee the design and development of new medical device products, ensuring compliance with industry standards (ISO 13485, FDA 21 CFR Part 820, etc.) and client requirements.
• Drive DFM and DFA efforts to optimize product designs for efficient, scalable production.
• Conduct design reviews, risk assessments, and FMEA to identify and mitigate potential design and manufacturing issues early in the development process.
• Provide technical direction on material selection, tolerance analysis, prototyping, and testing to meet both design intent and manufacturability.
• Solve complex engineering challenges, applying sound principles and innovative solutions to ensure product safety, reliability, and performance.
• Implement continuous improvement initiatives focused on enhancing design processes and reducing lead times and manufacturing costs.
• Ensure all design engineering activities comply with applicable regulatory and quality requirements.
• Prepare and maintain detailed technical documentation, including design history files (DHF), risk management files, and product specifications to support regulatory submissions and audits.
• Work closely with clients to understand project requirements, provide technical guidance, and ensure satisfaction with delivered products.
• Address and resolve client concerns related to design and manufacturability, providing timely solutions and proactive support.

Requirements

• A bachelor's degree in mechanical engineering, Biomedical Engineering, or equivalent is required; an advanced degree in any of these fields is preferred.
• A minimum of 8 years of experience with a proven track record of successful design within a regulated product development environment; medical device is preferred.
• At least 3 years in a leadership or management role within a contract manufacturing or medical device design environment.
• Experience in SolidWorks is a must.

Benefits

• 401(k)
• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Referral program
• Vision insurance