The Mechanical Engineer will be responsible for working within cross functional teams to understand requirements and develop medical device hardware to meet regulatory and customer expectations. The position includes the design and development, prototyping, testing and documentation of medical device hardware products. This position will have the opportunity to excel within a high-energy, small, focused team environment, maintain a strong sense of shared responsibility and shared reward, and to make work fun and interesting.
Essential Duties and Functions: Mechanical/Hardware Engineer
- Work on multiple projects to develop new medical device products, ensuring the specifications align with overall product and system specifications.
- Conduct research and prototyping activities to assess the feasibility of new product designs and the ability to meet requirements.
- Responsible for the design of our next generation products.
- Contribute to development of the mechanical product architecture, including detailed design of mechanical components, including complex assemblies and sub-systems.
- Work directly with suppliers and contract manufacturers in support of system assembly build activities.
- Participate in product design and development reviews and product phase reviews. Complete all action items as directed.
- Provide input for project schedules. Ensure assigned tasks are completed per project schedule.
- Work closely with cross-functional groups, including Software Engineering counterparts to define product requirements.
- Work closely with software Team for firmware/hardware integration.
- Assess hardware mechanical failures as part of customer complaint investigations.
- Can own and complete tasks with the time pressures typical of new product development.
- Understand and adhere to the company’s Code of Ethical Conduct and ensure that personal actions, and the actions of employees supervised, comply with the policies, regulations and laws applicable to the business.
- Maintain a professional and credible image with key physicians, consultants, suppliers, and co-workers.
- Engage with end-users to identify user-needs and convert into actionable designs.
- Provide demonstrations of the mechanical systems to both technical and non-technical audiences.
- Perform other duties as assigned.
- Ensure all activities conform to FDA requirements for GMP/QSR and ISO13485.
- Support a work environment of continuous improvement that supports Galen’s Quality Policy, Quality System and the appropriate regulations for the area supported.
- Keep manager informed of changes in work schedule and/or workload.
- Regularly recommend and implement methods of improving the customer experience.
Minimum BSME or relevant engineering field. MS/MSE or PhD preferred.
Minimum 4 years of industry mechanical or hardware engineering experience.
- Experience in designing medical device products using a broad range of processes and materials, especially design of user-facing and sterilizable hardware.
- Experience with the development and integration of electro-mechanical components, such as flex circuits, batteries, and antennae.
- Experience in the areas of Tolerance Analysis, FEA, Thermal Design, DFMEA, DFA, etc.
- Experience designing to industry standards (IEC, ISO, ASME, etc.)
- Strong problem-solving skills.
- Strong mathematics skills, particularly vector calculus, linear algebra and differential equations; ability to describe complex mechanical systems in mathematical models.
- Professional and positive approach, self-motivated, team player, creative.
- Excellent written, verbal, and presentation skills.
- Self-motivated, self-directed, and able to thrive in a fast-paced environment.
- Ability to work cross-functionally with a distributed team across Engineering, Design, Customer Success, Marketing and Business Development.
- Experience in the Medical Device Industry strongly preferred.
- Expertise in 3D MCAD, Solidworks preferred.
- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Other duties as assigned
To apply for this job email your details to firstname.lastname@example.org