Job Title

Requisition

Location

Additional Locations

Job Description

The Team Lead, Medical Device Production provides leadership, ensures safety, quality, and productivity goals are met. The Team Lead, Medical Device Production supports GMP Manufacturing processes, handle operational tasks, and drive continuous improvement. Acting as a subject matter expert, the Team Lead, Medical Device Production oversees equipment maintenance and effectively communicate priorities to the team. The Team Lead, Medical Device Production ensures work aligns with quality standards and regulations.

• Provide operational guidance for day-to-day cGMP device manufacturing production and service activities.

• Make necessary judgment call to align with schedule changes by prioritizing specific duties to stay on schedule.

• Communicate with production leadership and warehouse teams to ensure materials are ready and staged each day.

• Oversee training of new employees

• Communicates with quality and facilities any time there is an issue with the product or equipment.

• Perform and document all assembly, test and repair work per established work rules, policies, and procedures.

• Provide guidance in problem diagnosis and resolution with team members.

• Successful completion of all training in a timely fashion.

• Serve as a key part of new hire selection and onboarding process.

• Assist in development and revisions of Standard Operating Procedures (SOP), Work Instructions (WI) device history records, or other quality documentation, as necessary, to support production processes.

• 5+ years of experience in Medical Device cGMP manufacturing or equivalent combination of manufacturing experience.

• Ability to work independently and motivate staff to meet required deadlines.

• Problem solving and process improvement skills.

• Demonstrated excellence in leadership, coaching and communication skills.

• Ability to facilitate change, foster innovation, and achieve results.

Preferred Qualifications:

• Bachelor's degree in related field.

• Strong SAP skills and experience.

• Six Sigma belt or LEAN ideology.

The role of the Team Lead, Medical Device Production is primarily an entry level management role within the Device Manufacturing department; this position will perform hands on value-add operations for device manufacturing in addition to providing help and guidance to other team members. Work will be split between executing plant-based device manufacturing operations and providing training, assigning tasks, setting priorities with direction from site leadership, team member guidance and troubleshooting help for other team members.

Clean, temperature-controlled environment. Ability to work scheduled or expanded shifts, holidays and/or off-shift duties, as necessary.

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