The Opto-Mechanical Engineer is part of the Cogmedix optical and mechanical engineering product development team. The Opto-Mechanical Engineer will participate in the success of laser, optical and mechanical engineering efforts for Engineering Services projects. Opto-Mechanical Engineer technical communications requirements include but is not limited to customers, suppliers and Cogmedix internal stakeholders and associates.
- Be part of 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.
- Work in a transparent manner, and practice practical optical and mechanical engineering best practices.
- With strong collaboration across departments, 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.
- Design to meet global product safety standards.
- Participate in optical and mechanical engineering execution of multiple complex projects from design, prototype, pilot production and transition to manufacturing.
- 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 optical and mechanical engineering services.
- Participate in optical and mechanical engineering compliant to design controls.
- Participate in 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 4 years of experience in medical device product development preferred. Other experience may be considered in lieu of the 4 years.
- Direct experience working within design controls (21 CFR 820.30) processes is preferred.
- 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 work ethics 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 is preferred.
- 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.