Senior Manufacturing Engineer

Job Summary

The Senior Manufacturing Engineer provides a key technical interface to a critical contract manufacturing relationship. The contract manufacturer provides a system consisting of electromechanical capital equipment as well as high-volume sterile disposables. These are hands-on manufacturing engineering roles focused heavily on supporting the production floor.

Key Responsibilities

• Create and execute validation plans, including IQ of process equipment and OQ and/or PQ of manufacturing processes.
• Lead manufacturing implementation of sustaining design initiatives.
• Detect, conceptualize, and execute improvement opportunities using a series of Lean and related tools and methodologies.
• Distill complex technical situations into meaningful summaries that are digestible by various stakeholders.
• Lead troubleshooting exercises to quickly get to solutions.
• Create and revise essential documents such as process flowcharts, PFMEA, and Process Control plans.
• Practice LEAN techniques and be able to facilitate lean kaizens.
• Interface with contract manufacturing staff and management to ensure that plans are followed and risks are mitigated.
• Work effectively with other functions such as research and development, Procurement, Design Quality Assurance, Regulatory Affairs, and Field Service in completion of duties and communication of relevant information.
• Interface with suppliers and Quality Engineering to resolve supplier quality issues.
• Monitor quality reports and field performance of assigned product line, identify trends, investigate problems and implement corrective actions.
• Actively supports and adheres to the Quality Policy and Quality System procedures.
• Other duties relating to above as may be required.
• Floor-based troubleshooting and issue resolution.
• Support for validated processes (understanding of validation required).
• Root cause analysis and corrective actions.
• Hands-on support across manufacturing and quality teams.
• Rapid response (firefighting mode) when issues occur.
• Compliance with med device documentation and regulatory expectations.

Required Skills

• Medical device industry experience.
• Extensive validation experience, including employment of sound statistical approach and authorship of solid protocols and/or reports.
• Advanced interpersonal skills; communication and emotional awareness is key to be successful in this role.
• Quick learner, driven and not afraid to experiment.
• Able to manage projects and lead and coordinate cross-functional teams.
• Thorough understanding of Lean Manufacturing principles required: 5S, Value Stream Mapping, Kanban, SMED, GEMBA mindset, KPI development and management.
• Good understanding of product lifecycle management (PLM) applications such as AGILE and ERP systems such as ORACLE, SAP, or BAAN.
• Experience with computer-aided design software required.
• Troubleshooting mindset and ability to respond to issues immediately.
• Knowledge of validation concepts (even though most work involves troubleshooting existing validated processes).
• Must be comfortable wearing safety shoes daily and being physically present on the floor most of the time.

Preferred Skills

• ORACLE preferred among ERP systems.
• Experience with LabVIEW highly preferred.
• SolidWorks preferred among CAD software.

Education Requirements

B.S. in Engineering, preferably in Mechanical, Electro-Mechanical, Electrical, or Industrial Engineering.

Required Experience

• 7 or more years' experience in Manufacturing and/or Manufacturing Engineering with working knowledge of electro-mechanical sub-assemblies.
• Minimum 2–3 years of medical device experience.

Nice-to-Have Experience

Total experience target is 7 years for Senior level; however, the hiring manager will consider strong candidates with 3–5 years if technically aligned.

Work Environment / Physical Requirements

• Sit; use hands to finger, handle, or feel objects, tools, or controls.
• Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl.
• Lifting and/or moving and carrying products weighing up to 50 pounds.
• Exposure to moving mechanical parts, vibration, and/or moderate noise levels.
• Exposure to hazardous chemicals or other materials (examples: isopropyl alcohol, Loctite); exposure is minimal.
• May work with or around high-voltage and radiation-generating equipment.
• Strong, hands-on floor presence is required; candidate must be physically present on the floor most of the time.

Benefits

• Medical, Vision, and Dental Insurance Plans.
• 401k Retirement Fund.

Important Notes

• Interview Process: Step 1 — 30-minute Teams video interview with hiring manager. Step 2 (Local candidates) — On-site, 2.5 to 3-hour interview, facility tour, meetings with leads and stakeholders. Step 2 (Non-local candidates) — Second, deeper Teams interview with lead team, manufacturing, and quality.
• No direct conversion plan; contract expected through end of calendar year. High performers may be considered for permanent placement depending on future openings.
• Looking specifically for manufacturing engineers with medical device or pharmaceutical experience.

About the Client

Innovative medical technology firm focused on women's health.

About GTT

GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company in Alaska. We highly value diverse and inclusive workplaces and support Fortune 500 organizations across banking, financial services, technology, life sciences, biotech, utilities, and retail sectors throughout the U.S. and Canada.

Job Number

26-03941

Industry

Manufacturing & Operations