As a member of the engineering services team, the Senior Mechanical Engineer will solve complex problems and participate in the specification, design, prototyping and testing of a diverse range of tooling, fixtures, design for manufacturability projects, and other customer product design needs. Under the direction of the Senior Vice President of Engineering, the engineer in this role will be performing design tasks of a complex technical nature requiring investigation of new technologies, and applying engineering design principles and practices. The Senior Mechanical Engineer is part is responsible for ensuring mechanical design is compliant with the Cogmedix Quality Systems, 21 CFR 820.30, and ISO 13485.
- Inspire and lead internal and external mechanical engineering team that must meet changing requirements and diverse advanced technologies to serve our medical customers’ time to market demands, patient safety requirements, and compliance obligations.
- Lead by example, and promote practical mechanical engineering best practices.
- With strong collaboration among all department leaders, provide technical leadership to the organization with a focus on design engineering.
- Maintain positive, high performance environment that fosters extraordinary customer satisfaction and associate retention.
- Recommend improvements to and maintain compliance to the Cogmedix Quality System, 21 CFR 820.30, and ISO 13485.
- Design, draft and mitigate Risk Management for mechanical product designs.
- Participate in internal and external FDA, ISO 13485, and customer audits as required.
- Provide leadership in design to meet global product safety standards.
- Provide mechanical engineering execution of multiple complex projects from design, prototype, pilot production and transition to manufacturing.
- Establish and practice Best Practices and Policies consistent with company goals and objectives in an open and collaborative manner.
- Reinforce and encourage company core values.
- Provide professional and technical assistance and guidance to associates and customers.
- Support the development of detailed proposals and SOW’s for mechanical engineering services.
- Provide engineering services such as work instruction development, tooling and fixture design.
- Other responsibilities as directed.
- Positive attitude, excellent communications skills, self-motivator, tenacious follow up, and superior organization skills.
- Superior customer service attitude.
- BS Degree in mechanical engineering.
- Minimum of 8 years of experience in medical device product development preferred. Other experience may be considered in lieu of the 8 years.
- Direct experience working within design controls (21 CFR 820.30) processes preferred.
- Excellent negotiation, problem solving, and written and oral communication skills, including experience presenting to customers and internal senior management.
- Excellent technical, problem solving and analytical abilities.
- Strong quality mindset a must.
- Must be flexible, possess strong leadership and interpersonal communication skills; ability to manage multiple priorities.
- Strong decision making capabilities and capacity to handle confidential information.
- Experience in phase gate product development preferred.
- A demonstrated commitment to company values.
- Proficient in Microsoft Office.
- Proficient with SolidWorks 3D CAD/CAM and PDM is required.
- Proficient in FEA is preferred.
- Pro/ENGINEER CAD/CAM experience is a plus.
- Laser experience is a plus.