Requirements:

We are looking for a Medical Device Engineering Process Manager to lead the electrical process engineering team. MPE Process Engineers are responsible for reviewing, developing, costing, creating processes, and creating work instructions for MPE build to print and designed products. This will include new and existing electrical assemblies and products through prototype builds, product and design reviews, quality reviews, and process reviews.

Responsibilities include:

1. Identifying new medical device product requirements and direct the MPE process engineering team to implement lean six sigma processes to perform mechanical and electrical assembly to medical requirements.
2. Leading the development and execution of MPE medical device transfer business.
3. Managing an electrical engineering staff to project timelines and milestones.
4. Creating engineering cost estimates to keep projects in budget.
5. Creating work area layouts to assemble new medical device products.
6. Directing the creation of electrical and mechanical assembly work instructions.
7. Directing the creation of assembly process controls.
8. Directing the creation of electrical assembly test protocols using Hi-Pot, ESD, and continuity test equipment.
9. Assisting MPE medical device customers as a technical resource to successfully launch new products.
10. Continuously improving the assembly processes for improved quality and efficiency using lean six sigma methodologies.

The ideal candidate will have:

• A bachelor's degree in Electrical Engineering.
• Previous experience using Solidworks Electrical, Draftsight, or Creo preferred
• Hands on experience in electrical and mechanical assembly manufacturing processes preferred.
• Previous experience in Printed Circuit Board (PCB) system integration
• Ability to interpret customer prints, documents and specifications
• Strong knowledge of Microsoft Office software applications (Outlook, Word, Excel, PowerPoint, Visio)
• Experience with Hi-Pot, ESD, oscilloscope, and continuity test equipment
• Ability to understand electrical schematics
• Able to work in a team environment
• FDA, ISO 13485, and IEC 60601 experience preferred
• Experience with ISO 15066, 10218 preferred
• Experience with IEC 11073 preferred
• Experience with advanced energy devices such as monopolar and bipolar, and advanced energy preferred
• Experience with opto-mechanical systems preferred
• Experience with design and testing for EMC/EMI preferred
• Experience with structured cabling preferred
• Experience with CoBots preferred
• Understanding of lean and/or six sigma methodologies preferred
• Previous experience working in and managing a clean room preferred
• Able to professionally interface with MPE customers