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Engineering - Manufacturing Engineer
2 months ago
- This role is responsible for ensuring daily safety, quality, output, and productivity goals for specified departments of responsibility, are met.
- The Manufacturing Lead will spend 50% of their time in direct labor/value-added production/assembly using a variety of specialized equipment, fixtures, work instructions and test equipment to perform a series of operations to correctly produce/assemble/test medical devices.
- They will spend their remaining time supporting production / test / assembly personnel in the efforts to achieve daily targets through resource allocation management, problem solving, procedure adherence assurance, training, and performance feedback.
- Work with Value Stream Supervisors / Managers and other Manufacturing Leads to manage and prioritize staffing assignments to ensure customer demand and the production schedules are met.
- Coordinate employee training to ensure that procedures are followed and meet all quality requirements.
- Support the execution of cross-training plans.
- Use basic problem-solving skills to independently solve common issues/challenges.
- Ability to independently troubleshoot common, simpler equipment issues via maintenance training.
- Report problems or concerns with quality, processes, equipment, materials and labor to Value Stream Supervisors.
- Work closely with support staff such as Technicians, Manufacturing/Quality Engineering, R&D, Value Stream Supervisors, and Materials/Warehouse personnel to resolve complex issues.
- Ensure adherence to documented Work Instructions and Standard Work.
- Facilitate regular team communication such as Daily Management meetings and provide necessary updates to the team.
- Provide shift changeover notes to the next shift.
- Identify and support continuous improvement efforts with Value Stream Supervisors.
- Participate as an active member of the production team and assist in product processing where needed, by becoming cross-trained in the most critical areas.
- Follow documented policies and procedures as designated by the company's Quality System.
- Complete required documentation relating to regulatory requirements.
- Minimum Education, Experience, and Behaviors.
- High school diploma and 5 years of related experience, or equivalent combination of education and experience.
- Ability to read and interpret documents such as safety rules, operating procedures, and maintenance instructions.
- Proficient with Microsoft Office (Word, Excel, Outlook).
- Ability to communicate effectively through oral and written communications.
- Ability to analyze and solve problems.
- Ability to work with others collaboratively.
- Strong organizational skills.
- Experience leading teams or projects strongly desired.
- Medical device manufacturing experience.
- Lean manufacturing and continuous process improvement experience.
- Must not have any chemical allergies: Work areas may contain adhesives, solvents, and chemical processes.
- Ability to frequently sit, stand, walk, reach with hands and arm's length, climb or balance, stoop, kneel, and crouch.
- Ability to regularly lift and/or move up to 10 pounds, occasionally lift and/or move up to 50 pounds.
- Specific vision requirements include close vision and color vision.
- Must be willing and able to conform to cleanroom practices with regard to apparel and personal hygiene.
