Manager, Production and Sustaining Engineering – Product Development & Realization Department
Location: CSA Medical Headquarters, Lexington, MA
The Manager of Production and Sustaining Engineering coordinates all engineering and production activities for new and existing products from the Contract Manufacturer (CM). The individual also identifies and oversees execution of sustaining engineering projects to improve device performance and reliability. The individual will lead and manage the production and sustaining engineering team.
Duties and Responsibilities
This may include but is not limited to the following:
- Manufacturing/operations representative on product development teams.
- Liaison between CSA Medical and Contract Manufacturer, acting as the primary point of contact for all communication between CSAM and CM.
- Assists Contract Manufacturer in the investigation and troubleshooting of manufacturing or design issues.
- Leads regular meetings with Contract Manufacturer to track progress and identify key issues related to CSAM products.
- Leads regular production forecast and inventory review meetings with appropriate CSA Medical personnel.
- Reviews and approves all Contract Manufacturer invoices.
- Responsible for design activities relating to component obsolescence, high failure items, and evaluation of design changes requested by suppliers.
- Identifies and carries out key sustaining engineering and continuous improvement projects to improve device performance and reliability.
- Coordinates design transfer activities and implementation of new products or design changes, including management of inventory upon release.
- Evaluates and approves deviation and NCMR reports from Contract Manufacturer with the appropriate CSA Medical personnel.
- Assists with test method development and validation (MSA/Gage R&R) by Contract Manufacturer, as required.
- Documentation and report writing (Medical Device Regulatory Standards).
- Laboratory work, safety and records maintenance.
Skills & Competencies
Position requirements, qualifications and experiences:
- B.S. Degree in Sciences or Engineering
- 3 – 6 years’ experience in medical device or manufacturing field
- Some travel required
- Willingness and ability to observe medical procedures
- Excellent teamwork and communication skills
- Strong Solidworks experience
- Strong commitment to customer service and order fulfillment
- Experience maintaining and updating product BOMs and drawings
- Strong experience with investigations and troubleshooting of technical issues
- Flexibility and adaptability to change, including an excellent ability to multi-task in a fast paced environment
- Self-motivated and organized
- Proven leadership and management skills, including project management
- Experience with FDA / QSR and ISO 13485
How to Apply:
Submit your resume and cover letter to firstname.lastname@example.org
CSA Medical, Inc. is an equal opportunity employer.