Staff NPI Engineer San Mateo, CA

Mendaera; San Mateo (CA); On-site; USD 150,000 - 200,000; Full time

Job description

Mendaera is developing technology that will enable all healthcare providers to do more for their patients. Our platform combines real-time imaging, robotics, and artificial intelligence to make precise and consistent intervention more accessible. Our aim is to eliminate barriers in the patient journey, accelerate recovery, delight customers, and reduce cost of care.

About the Opportunity

Mendaera is looking for a Staff NPI (New Product Introduction) Engineer to help lead and execute the design transfer of the robot and cart product manufacturing lines to production. The NPI Engineer will bring hands-on expertise and extensive knowledge regarding the manufacture of electromechanical products. The NPI Engineer will have ownership of the internal and external manufacturing processes and drive continuous improvement to increase quality, delivery, and reduce cost, partnering with R&D, Operations, and Quality. The annual salary range for this role is $168,000-$211,000.

About You

We are looking for candidates who thrive in fast-paced environments; embrace ambiguity, can create work-product from scratch; possess critical thinking ability; and are detail-oriented.

Responsibilities include:

1. Lead the design transfer of the capital equipment product lines, including setting up and optimizing the manufacturing lines.
2. Lead DFM/DFA activities, working closely with the R&D engineers, Operations, and suppliers to ensure the components can be manufactured at the highest quality and lowest cost possible.
3. Enhance the internal manufacturing process by improving the assembly fixture designs and documentation (MPI and Traveler/LHR) to maximize the line capacity, throughput, and highest first pass yield.
4. Lead the pFMEA analysis, equipment, and process qualifications activities, including writing protocols and reports.
5. Perform root cause analysis and implement corrective actions to mitigate and prevent field issues/escapes.
6. Collaborate with suppliers to implement process control plans and resolve quality issues.
7. Work cross-functionally to support supplier audits and component sourcing.
8. Lead process capability analysis (Cpk) to identify improvements in the processes.
9. May require some travel to visit suppliers and CMs.

Desired skills and experience:

1. BS or MS in mechanical engineering, manufacturing engineering, or equivalent discipline.
2. 8 years of experience in industry or equivalent.
3. Experience manufacturing complex, tight tolerance designs in the medical device or similarly regulated industry.
4. Experience designing and fabricating assembly fixtures.
5. Manufacturing process expertise including cable assembly, molding, machining, and stamping.
6. Expertise performing process characterization/development, IQ/OQ/PQs, and pFMEA.
7. Extensive experience with root cause analysis and problem-solving for both technical and process issues.
8. Working knowledge of design control and cGMP requirements for medical device manufacturing per FDA QSR and ISO13485-2003 or ISO9001 and EN46001.
9. Working knowledge of CAD (Solidworks or other) software.