Electronics Manufacturing Engineer CardioMEMS

GENERAL FUNCTION:

Provide manufacturing engineering support in sustaining, developing, and bringing to market innovative medical products.

MAJOR DUTIES & RESPONSIBILITIES:

1. Perform Process Validation activities including Supplier/Component qualifications of electronic boards, assemblies and components. Prepare plans, protocols, and reports as required. Evaluate, monitor, and improve supplier performance. Participate in supplier audits.
2. Act as engineering support for in-house production personnel and assist with product non-conformances and other production issues. Perform root cause investigations and implement corrective and preventative actions as required.
3. Perform Manufacturing transfer to contract manufacturer. Evaluate, monitor, and improve contract manufacturer performance.
4. Develop and maintain DMR, Bill of materials, and other production documentation. Initiate, manage and/or participate in Engineer change notices.
5. Perform obsolescence analysis and recommend alternate components.
6. Develop and maintain a database of production and test data. Analyze processes and implement process, cost, and/or quality improvements as necessary. Implement corrective actions for statistically out-of-control processes.
7. Assist with cost of goods analysis and budgeting.
8. Design and fabricate tools/fixtures to improve manufacturing processes as required.
9. Act as gatekeeper for new products being transitioned to production. Assess manufacturability of the design and provide design for manufacturability input.
10. Perform process risk analyses and implement manufacturing controls to mitigate risk.
11. Improve in-process testing capability and throughput. Work with Electronics Software Engineering to incorporate new test features in test software. Design and fabricate test fixtures as required.

QUALIFICATIONS:

1. BS degree in Electrical Engineering or equivalent with at least 5 years work experience as an electronics manufacturing engineer or equivalent. Experience with medical electronics or other regulated industry preferred.
2. Experience developing manufacturing routers/travelers, work instructions, procedures, and illustrations.
3. Experience with new product introduction and ramp-up.
4. Experience designing manufacturing/assembly tools and fixtures preferred.
5. Ability to provide technical guidance to operators and other production personnel.
6. Knowledge of ISO and/or FDA quality system regulations as it pertains to design transfer and process control.
7. Knowledge of Statistical Process Control principles and methods.
8. Familiarity/experience with continuous improvement methodologies (e.g. Six Sigma).
9. Excellent written, verbal and interpersonal communications skills.
10. Excellent project management skills.
11. Excellent computer skills.

Location:	387 Technology Circle Northwest Suite 500 Atlanta, GA 30313 United States