Fabrication Operations Leader - Medical Device Manufacturing

Lead the Flow. Build the Future.

Picture your day starting on the production floor. You kick off a daily production review walk, align priorities across shifts, and make rapid corrections to keep product moving at established lead-times through the manufacturing cell. You track staffing against key constraints, confirm cross-training coverage, and set overtime plans as needed. Throughout the day you serve as the go-to resource for product and process knowledge in your department or Value Stream—coordinating with Facilities, Maintenance, HR, Quality, and Engineering to keep operations synchronized.

Quality and compliance are second nature. You conduct spot quality checks, 5S audits, and Layered Process Audits, and ensure day-to-day adherence to Avalign and FDA QSR requirements. You keep Team Members trained and current in GMP, EHS, and Quality Systems. You proactively inform leadership of critical developments and escalate issues when appropriate. And you invest in people—recruiting, developing, and coaching hourly Team Members, delivering clear feedback, and recognizing wins.

Your Impact

• Provide leadership for all production Team Members within the fabrication department or Value Stream, across all shifts.
• Own day-to-day supervision: maintain time, attendance, and disciplinary action records for each direct report in a timely manner.
• Ensure ongoing compliance with Avalign and FDA QSR requirements.
• Perform spot quality checks, 5S audits, and Layered Process Audits.
• Drive and lead continuous improvement projects.
• Keep Team Members trained and current in GMP, EHS, and Quality Systems.
• Keep management informed of significant operational developments.
• Manage key constraints and staffing to meet plan.
• Maintain product flow at established lead-times through the manufacturing cell.
• Recruit, develop, promote, and when necessary, take disciplinary action for hourly Team Members.
• Oversee performance management for hourly Team Members, including preparing and delivering annual performance reviews.
• Set direction and drive accountability for off-shift supervision across production, staffing, and quality needs.
• Serve as the manufacturing point person for product and process knowledge for the department or Value Stream.
• Act as the primary contact for the department/Value Stream with Facilities, Maintenance, HR, Quality, and Engineering.
• Lead the daily production review walk; implement corrections and escalate when needed.
• Establish production plans across all shifts and determine overtime needs.
• Define staffing needs and cross-training plans for the department across all shifts.
• Provide manufacturing feedback throughout the Engineering change process.
• Direct, coordinate, and evaluate non-exempt operators and team leads.
• Carry out supervisory responsibilities in accordance with organizational policies and applicable laws.
• Conduct interviewing, hiring, training, and development; plan, assign, and direct work; appraise performance; reward and discipline employees; address complaints and resolve problems.

Qualifications You Bring

• High school diploma or GED required; bachelor’s degree preferred.
• Three or more years of combined industry experience (biomedical, medical device) and/or military experience.
• Eight years of combined experience across industry, military, and/or related areas (general manufacturing, quality, or logistics); a combination of education and experience will be considered.
• Leadership experience preferred, including military leadership.

Who Thrives Here

• A self-starter energized by a fast-paced environment.
• A quick learner eager to deepen expertise in manufacturing processes.
• Reliable, accountable, and present when it counts.
• Open, cooperative, positive, and team-oriented.
• Strong planner who can execute across multiple teams.
• Clear and effective written and verbal communicator.

What You Won’t Do

• Feel stuck – we offer great opportunities to advance and learn.
• Get bored – we make a high variety of products, so no day is the same.
• Feel like a number – we’re a close-knit bunch and always have each other’s backs.

Tools of the Trade

• Continuous Improvement
• Standard Operating Procedures (SOPs)
• Production Optimization
• Operational Metrics & KPI Management
• Production Planning & Scheduling

Rewards & Benefits

• Competitive compensation and benefits package
• Comprehensive medical, dental, and vision insurance
• Paid vacation and 10 observed paid holidays per year
• Employer funded Basic Life and AD&D insurance
• Employer funded STD and LTD insurance
• Tuition reimbursement
• Great 401(k) with company match
• Generous employee referral bonus program
• Thriving, performance-based culture with promotion from within and career advancement
• Temperature controlled environment
• Community involvement with investments that give back
• Additional free resources such as travel assistance, EAP, etc.