Production Supervisor (weekend shift)

Job Title: Production Supervisor

Shift: Weekend (Friday - Sunday, 6:00am to 6:30pm)

Department: Manufacturing

Status: Full Time – Exempt

Reporting To: Local Business Unit Leader

Position Purpose:

The Production Supervisor is responsible for the overall performance of the manufacturing shift across the BU. This position supervises Lead Operators and the broader production team, ensures daily shipment commitments and quality standards are met, and drives personnel development through structured performance management. The Supervisor serves as the primary decision-maker on shift, aligning with the Planner on production execution and escalating to the Business Unit Leader as needed.

Responsibilities:

Shift Leadership & Execution:

• Lead the BU manufacturing team across all cells during the shift to meet daily shipment demands while fulfilling all quality system requirements
• Define work plans and allocate resources in alignment with the Planner’s production schedule; resolve resource conflicts and reprioritize as needed
• Execute formal face-to-face shift handoff between supervisors to communicate machine status, open and hot lots, staffing changes, and escalated issues
• Coordinate machine repairs and maintenance through the appropriate channels to minimize downtime across the shift
• Ensuring cleanroom, controlled environments, and shared areas always meet safety and housekeeping standards

Quality & Compliance:

• Ensure correct coating, inspection, and packaging instructions are followed and that DHR documentation requirements are met for every lot
• Manage customer parts, raw materials, lot separation, line clearance, and traceability procedures across the BU
• Resolve quality deviations, approve non-conformance escalations from Lead Operators, and coordinate with Quality on CAPAs as needed
• Maintain shift-level audit readiness; ensure the team operates in full compliance with ISO 13485, FDA 21 CFR Part 820, and Parts 210 & 211

Personnel Development & Performance Management:

• Lead and engage with direct reports on hiring recommendations, performance-related issues, and disciplinary actions
• Conduct and document 30/60/90-day performance evaluations for all new hires on shift
• Provide ongoing coaching and feedback to Lead Operators; support their development.
• Coordinate with the Planner and Lead Operators for training program execution, qualification status, and operator readiness for new programs
• Identify talent, flag performance risks, and escalate unresolved people issues to the Business Unit Leader
• Authorize overtime and payroll adjustments in accordance with company policy and Business Unit Leader guidance
• Make or formally endorse hiring and termination recommendations; escalate decisions to the Business Unit Leader and HR as required
• Approve CAPAs and non-conformance dispositions in coordination with Quality

Key Performance Indicators (KPIs) — Supervisor Level:

• On-time delivery (OTD): percentage of lots shipped on or before the committed date
• Yield rate: first-pass yield across all programs in the BU per shift
• Scrap rate: non-conforming parts as a percentage of total parts processed across the BU
• Qualification rate: percentage of operators qualified to plan on assigned programs
• Time-to-qualification: average days from hire to Operator II qualification
• 30/60/90-day evaluation completion rate: 100% of new hires evaluated on schedule
• Training completion: ISOX records current and complete within 48 hours of each OJT step

Education, Qualifications & Experience:

• Associate’s Degree in a technical or business field required; Bachelor’s Degree in Operations or Engineering preferred
• 3 years of supervisory or lead experience in a regulated manufacturing environment
• Familiarity with Lean Manufacturing concepts and continuous improvement methodologies
• Experience in a laboratory or production environment requiring high traceability (ISO 13485 or FDA-regulated preferred)
• Strong analytical skills; ability to interpret production data and drive data-based decisions
• Demonstrated ability to manage people: coaching, performance conversations, conflict resolution
• Computer proficiency in Microsoft Excel and ERP/inventory management systems
• Strong verbal and written communication skills; ability to interact effectively across all levels of the organization

Working Conditions and Health & Safety:

• ISO Class 7 Cleanroom environment
• Employee is required to use appropriate PPE including, but not limited to, nitrile or latex gloves, lab coat, hair bonnet, shoe covers, beard cover, safety glasses, hearing protection, face shield, or respiratory mask while working in a lab or manufacturing space

Harland Medical Systems’ commitment to ensure employee health and safety is a priority. Personnel engaged in manufacturing shall obtain training required by ISO 13485, FDA 21 CFR Part 820, FDA 21 CFR Parts 210 & 211, and Harland Medical Systems’ internal procedures, where deemed appropriate per assigned job functions.

Pay: $70,000.00 - $90,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Vision insurance

Application Question(s):

• Does the weekend shift, Friday through Sunday, 6:00am to 6:30pm work for you?

Education:

• Associate (Preferred)

Experience:

• Production Supervisor: 3 years (Preferred)
• Lean manufacturing: 1 year (Preferred)

Ability to Commute:

• Eden Prairie, MN 55344 (Preferred)

Work Location: In person

Salary : $70,000 - $90,000