Manufacturing Operations Manager/Sr. Manager

You can count on Nonin. Our vision is to improve people’s lives by creating noninvasive medical devices people can count on. Nonin’s culture is grounded in our mission, and we live by our cultural tenets of courage, ownership, and agility. The courage to challenge assumptions and take risks, the ownership to act with accountability, and the agility to constantly innovate and move with speed. It is these tenants that have made Nonin the technology leader for over 40 years. As a privately owned, small company, you are not one among many, but an important part of our success with the ability to learn, grow and impact all aspects of the business. So, if you are looking for a smaller company to spread your wings while making big company impacts, join Nonin today… Together we will improve lives around the world, including your own.

The benefits of working at Nonin include:

• Financial Security: 401(k) Employer Match, Annual Incentive and/or Profit-sharing Plans
• Health and Wellness: Medical, Dental & Vision, and voluntary benefit offerings
• Flexibility: Paid Time Off + Personal Days, Paid Parental Leave

Essential Job Functions:

• Responsible for overall leadership for Materials Handling, Warehouse, Distribution, Production, Manufacturing Engineering, and Process Development.
• Establish goals, priorities and metrics across the value stream to ensure focused execution toward meeting or exceeding business objectives.
• Ensure compliance with 21 CFR Part 820 (Quality Management System), FDA, ISO 13485, EU MDR and other quality and regulatory requirements.
• Ensure that weekly SKU level manufacturing attainment goals are met while achieving supply chain continuity by proactively mitigating risk.
• Use formal project management tools including A3’s and Gantt charts to communicate status, track execution, and promote employee accountability
• Coordinate between R&D, Quality, Regulatory, Operations, and Supply Chain to deliver products on time, within budget, and to specification.
• Contribute to new product development initiatives by developing manufacturing processes and driving engineering process improvements that create efficiency and reduce costs.
• Design and optimize manufacturing processes and design transfers for high quality and low cost.
• Partner with Quality to utilize defect prevention and permanent corrective action tools.
• Embed a continuous improvement mindset by using Lean Principles to develop a continuous improvement culture rooted in waste elimination, labor efficiency, and visual management. Apply shop floor linear flow and 5S techniques.
• Lead Safety Committee to ensure a safe and productive work environment and implement any necessary corrective actions (Gemba walks).
• Instill, promote, and drive a culture where employees are listened to, supported, and encouraged to participate in cross-functional Kaizen improvement teams. Serve as a model for promoting safety, quality, supply continuity, and fiscal responsiveness.
• Ensure employees understand and follow all company policies, required procedures, and standard safety, quality, and production practices.

Minimum Qualifications:

• BS degree in Electrical or Mechanical Engineering or equivalent related experience.
• 7+ years of progressive experience within medical device manufacturing operations.
• 3+ years of supervisory/leadership experience

 Required Knowledge, Skills & Abilities:

• Proficiency in design controls, risk analysis, manufacturing process validation, and regulatory submissions
• Proven results driven leadership, with the ability to work under pressure in a fast-paced, time-sensitive environment with shifting priorities and multiple deadlines
• Understanding of Supply Chain Sourcing and Planning industry standard work
• GMP/ISO13485 requirements experience
• Demonstrated success applying Lean/Six Sigma methodologies
• Effective collaboration and communication skills across all levels of the organization
• Effective interpersonal skills with ability to resolve conflict
• Demonstrated ability to creatively solve problems with pragmatic solutions

Preferred Qualifications:

• Warehouse and Distribution center management experience including international shipments
• Familiarity with ERP software functionality
• APICS certification

Physical Requirements:

• Ability to frequently sit, stand, walk, reach with hands at arm’s length, climb or balance, stoop, kneel, and crouch.
• Ability to regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds, and occasionally lift and/or move up to 50 pounds.