Process Engineering Manager san jose, ca ref - Military veterans preferred

Process Engineering Manager san jose, ca ref

The Manager of Process Engineering is responsible for providing technical leadership and direction to a team of talented engineers. The successful candidate will have extensive experience in the areas of process development/optimization, continuous improvement, and cost reduction as well as verification & validation activities in a fast-paced environment.

This is a hands-on position that requires interaction and collaboration with cross-functional teams including R&D Engineering, Automation Engineering, Manufacturing, Material, Quality, and safety.

Requirements

Develop standards and key performance metrics to reduce variability as well as improving quality, throughput, and efficiency Actively participate in early design concept reviews with R&D and Automation Engineering and provide objective feedback to ensure manufacturing robustness Perform equipment characterization and define process windows by creating appropriate DOE’s and utilizing statistical data analysis Own the verification/validation activities including generation of IQ/OQ/PQ protocols, execution and final reports as well as creating SOP’s, MPI’s LHR’s and providing appropriate training Recommend production layouts for automation equipment and material flow for maximum efficiency Investigate manufacturing process failures, identify root cause and work with other groups as needed to ensure timely resolution Provide support for existing equipment and ensure proper documentation and training Lead new product transfer and manufacturing scale-up activities utilizing best manufacturing techniques Champion and foster a mindset of quality and continuous improvement Adhere to project timelines, identify risks/issues, and recommend mitigations Attract/hire top talent and ensure retention by providing coaching/mentoring and encouraging career growth Comply with company’s policies and guidelines regarding design control, validation activities and documentation Qualifications

Bachelor’s Degree in Chemical, Mechanical, Manufacturing, or related engineering fields 5-7 years hands-on experience in the medical device field with proven track record of process development/optimization and validation Minimum 3 years of proven leadership and people management Excellent verbal, written, presentation and interpersonal skills Prior experience with FDA regulations and ISO, cGMP, QMS standards Strong analytical and problem-solving skills including but not limited to DOE and statistical data analysis Extensive experience with process capability studies, FMEA, GR&R, SPC and process development/validation Knowledge and experience with plastic injection molding as well as semi-automated and fully automated machines/processes Knowledge of material science and polymer chemistry Experience with Statistical Software tools such as Minitab or JMP Experience with Lean manufacturing Preferred Qualifications

Advanced engineering degree Familiarity with aseptic manufacturing Project management experience Knowledge and experience in plastics assembly techniques Travel

Up to 10%

Pre screen questionnaire:

1. Where is the candidate located? If candidate is not near the job location, please explain relocation plan in detail (e.g. timeline, relocating with family, selling/buying property)

2. What is the candidate’s desired total compensation? (Please specify base salary vs. commission/bonus expectation)

3. Has the candidate applied or been interviewed for any role with this company in the past? If so, please provide details.

4. What is the candidate’s highest level of education?

5. What is the candidate’s work authorization status?

6. Please provide the link to candidate’s LinkedIn profile:

7. Outline the candidate's experience within the medical device field including: process development, optimization, and validation.

8. Outline the candidate's experience with leadership.

9. Outline the candidate's experience with plastic injection molding as well as semi-automated and fully automated machines/processes.

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