The Opto-Mechanical Engineering Manager will lead the Cogmedix optical and mechanical engineering product development team compliantly within the Cogmedix Quality Systems, 21 CFR 820.30, and ISO 13485. The Opto-Mechanical Engineering Manager is responsible for the success of laser, optical and mechanical engineering efforts for Engineering Services projects. Opto-Mechanical Engineering Manager technical communications requirements include but is not limited to customers, suppliers and Cogmedix internal stakeholders and associates.
- Inspire, lead, organize and manage internal and external optical and 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.
- Manage in a transparent manner, lead by example, and promote practical optical and 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.
- Lead and develop the optical and mechanical engineering team resources, engineering core competency, budget, and individual program performance metrics.
- Oversee optical and mechanical engineering execution of multiple complex projects from design, prototype, pilot production and transition to manufacturing.
- Establish 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 optical and mechanical engineering services.
- Lead and execute optical and mechanical engineering compliant to design controls.
- Lead and execute optical and mechanical engineering compliant to medical device product safety regulations such as IEC 60601-1 and laser safety regulations such as IEC 60601-2-22.
- 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 optical and/or mechanical engineering. MS preferred.
- Minimum of 10 years of experience in medical device product development preferred. Other experience may be considered in lieu of the 10 years.
- Direct experience working within design controls (21 CFR 820.30) processes required.
- Excellent negotiation, written and oral communication skills, including experience presenting to customers and internal senior management.
- Excellent organizational skills with a commitment to meeting deadlines and expectations while ensuring overall compliance and quality of delivery.
- 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 required.
- A demonstrated commitment to company values.
- Proficient in Microsoft Office.
- Proficient with SolidWorks 3D CAD/CAM and PDM is required.
- Laser and optical design experience is required.
- Experience in FEA is a plus.
- ZEMAX and/or TRACEPRO experience is a plus.