Medical Device Fabrication Operations Leader

Avalign Technologies•Greenwood, IN

About The Position

Build 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

Requirements

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.
Proven ability to plan and execute across teams and shifts in a fast-paced environment.
Effective communicator; self-starter; dependable team player.

Nice To Haves

Leadership experience preferred, including military leadership.

Responsibilities

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.