Our Client is a growing, innovation-driven company on the forefront of delivering medical devices to save lives, and software solutions to improve efficiency. With customers in more than 140 countries, we continue to expand our reach, as well as our product offerings. Hospitals, emergency medical services (EMS), and others trust us to provide high-quality products and exceptional customer service. Our client’s products are used every day across the globe to save the lives of people who suffer sudden cardiac arrest. From Real CPR Help® technology—an industry first—to the world’s only wearable defibrillator, our capabilities and features set us apart. But none of this would be possible without the motivation and dedication of our client’s employees, and we are invested in their success.
As a Senior Mechanical Engineer on our Resuscitation R&D team, you will design parts, assemblies, and enclosures for new and revised Ventilator and Aspirator products. You will also collaborate with a cross-functional team of engineers and scientists in support of flow/pneumatics, shock/vibration control, ingress protection, EMI isolation, and thermal management per defined product goals. The team member is also expected to apply good design practices, procedures, and design criteria in the development of assemblies, subsystems and fixtures. The role is primarily technical in nature but may include limited project management duties.
- Layout and develop new product designs. Complete engineering mechanics analysis, thermal/flow analysis, and tolerance analysis.
- Complete design refinement to support Design for Manufacture and Assembly objectives.
- Create detailed design documentation of new and revised products including part drawings, assembly documents, Bills of Materials, and purchasing specifications.
- Create Engineering Change Orders to enable control and release of designs to production under our client’s Quality System.
- Support document preparation for test and regulatory submission of new/existing designs.
- Support development of risk assessments and FMEA for creation of the design history file.
- Lead and participate in technical design reviews for new or revised products and other projects as assigned.
- Present new designs to suppliers and evaluate samples and prototypes for build and test.
- Conduct part, subsystem, and system verification and validation testing of new designs complete with supporting documentation.
- Conduct design of experiments and laboratory testing of new and legacy products and document results.
- Support management activity in preparation of schedule, budget and project reporting.
Required/Preferred Education and Experience:
- Proficiency with SolidWorks including Design, Drawing, and Simulation. CSWP Preferred
- Working knowledge of drawing creation per ASME Y 14.5 2009
- Ability to design, document and analyze parts encountered in packaging of embedded systems (such as molded plastic housings, sheet metal, gaskets, PCBs, LCDs, cables and labels)
- Strong written and verbal communication skills
- Excellent problem solving shills
- Ability to work with minimal oversight, i.e., “self-motivated”
- Ability to work independently and with a non-co-located team
- A demonstrated commitment to continuous improvement of job related skills
- Ability to handle confidential information with discretion and skill
- Working knowledge of IEC 60601 is a plus
- Bachelor of Science in Mechanical Engineering or equivalent. MS degree preferred.
- Requires a minimum of 7 years Mechanical Engineering and product design experience.
- Experience in medical or other highly regulated industry is required.
- Experience with pneumatic/compressor driven systems is a plus.