Medical Device Fabrication Operations Leader

Job Description

Job DescriptionBuild and Lead a High-Performing Fabrication Operation

Our mission is to deliver safe, high-quality medical device components—on time, every time. As the Fabrication Operations Leader, you’ll orchestrate people, processes, and equipment across all shifts to achieve world-class outcomes in safety, quality, delivery, and engagement.

Your Impact

• Deliver the plan: create and manage production schedules; post daily assignments; set overtime and staffing levels to meet demand.
• Uphold compliance: ensure daily adherence to Avalign policies and FDA QSR, with strong GMP, EHS, and Quality Systems practices.
• Elevate performance: conduct spot quality checks, 5S audits, and Layered Process Audits; drive corrective actions and continuous improvement.
• Optimize flow: remove bottlenecks, manage constraints, and keep product moving at established lead-times through the manufacturing cell.
• Lead people: supervise hourly operators and team leads; coach, recognize, and hold teams accountable across all shifts.
• Build talent: recruit, onboard, cross-train, develop, promote, and complete performance reviews; maintain time, attendance, and disciplinary records.
• Be the hub: serve as the department point person for Facilities, Maintenance, HR, Quality, and Engineering; communicate status and issues to management.
• Advance processes: provide manufacturing input to the Engineering Change process and support problem-solving and issue escalation.

What You’ll Need to Succeed

• High school diploma or GED required; bachelor’s degree preferred.
• 3+ years in biomedical/medical device and/or military settings.
• 8+ years combined experience spanning industry, military, and/or related areas (manufacturing, quality, logistics); equivalent combinations considered.
• Leadership experience preferred, including military leadership.
• Proven ability to plan and execute across teams and shifts in a fast-paced environment.
• Effective communicator; self-starter; dependable team player.

Why You’ll Love It Here

• Real mobility—advance your career while learning new processes and technologies.
• Variety—broad product mix, constant problem-solving, meaningful impact.
• Community—supportive peers and leaders who invest in your success.

Rewards & Benefits

• Competitive compensation and benefits.
• Medical, dental, and vision coverage.
• Paid vacation plus 10 observed paid holidays annually.
• Employer-funded Basic Life and AD&D insurance.
• Employer-funded Short-Term and Long-Term Disability.
• Tuition reimbursement.
• 401(k) with company match.
• Generous employee referral bonus program.
• Performance-based culture with promotion from within.
• Temperature-controlled facility.
• Community involvement and giving initiatives.
• Extras like travel assistance and EAP.

Core Competencies

• Production Optimization
• Production Planning & Scheduling