Product Development Manufacturing Supervisor

Terumo Cardiovascular Group; Elkton (MD); On-site; USD 75,000 - 90,000; Full time

Job summary

A leading medical device company in Elkton is seeking a Product Development Manufacturing Supervisor. This role involves overseeing pilot line operations, managing a team, and ensuring compliance with safety and quality standards. The ideal candidate has extensive experience in manufacturing and supervisory roles within regulated industries.

Benefits

Annual bonus

Paid vacation

401(k) with matching contributions

Health, dental, and vision benefits

Tuition reimbursement

Qualifications

• 4+ years in manufacturing, including 2 in regulated industry.
• 2-3 years supervisory experience preferred.
• Ability to follow GMP and ISO standards.

Responsibilities

• Manage daily operations of the Pilot Line areas.
• Provide training, support, and motivation to staff.
• Ensure compliance with quality and safety regulations.

Skills

Leadership

Organizational skills

Communication

Problem Solving

Education

High School diploma

Advanced education preferred

Tools

Microsoft Excel

Microsoft Word

Microsoft PowerPoint

Microsoft Outlook

Job description

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Product Development Manufacturing Supervisor

Location:

Elkton, MD, US

Company: Terumo Medical Corporation

Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation; one of the world’s leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products.

The Product Development (PD) Pilot Line supports PD projects from feasibility through design verification (DV) and transfer into production. In collaboration with PD, the PD Pilot Line is responsible for iterating on protype designs throughout the development process as well as larger scale builds on a stable design for DV activities. The PD Pilot Line Manufacturing Supervisor will be responsible for managing build schedules and daily operations of PD Pilot Line areas, as well as managing (supervising, directing, mentoring, motivating, training, etc.) a small team of direct reports.

The PD Pilot Line Manufacturing Supervisor will partner with Product Development and Manufacturing leadership in order to meet Company goals for safety, quality, and productivity. In addition, this role is responsible for ensuring product traceability and engineering specifications meet the needs of the development activities and supporting the transition of NPD Pilot line process/equipment into production for commercial distribution.

• Associate is responsible to follow requirements of applicable national and international regulations
• Oversees the day-to-day operations of the Pilot Line areas (i.e. daily interaction and communication of staff, setting goals and objectives, planning schedules, preventative maintenance/maintenance repair, tracking production results, etc.)
• Provides a safe work environment and resolves any safety issues that arise
• Provides training, support, and motivation to staff
• Continually improves product quality through analyzing, identifying, and eliminating root causes and implementing a corrective action (i.e. increase running efficiency, increase yield rates to reduce waste and improve outputs, 100 percent attainment of production, schedule, etc.)
• Coordinates and interacts daily with support groups
• Maintains expenses within budget
• Maintains proper raw material inventory levels required to meet the build needs
• Associate is responsible to follow requirements of TMC Quality System; including but not limited to: process controls, inspection procedures, document/data control, and change control practices. Establish and promote a work environment amongst co-workers and direct reports that supports compliance with the TMC Quality System and Terumo’s policies
• Participates in project performance team meetings in order to provide ideas, methods, or processes for performance improvement
• Participates in project and department meetings weekly and monthly, as needed.
• Effectively communicate and coordinate activities to align with PMO, Engineering, Quality Assurance, Purchasing, PDC, Human Resources, Accounting/EDP, etc.
  

Job Responsibilities (continued)

• Follow all established Environmental Health & Safety and Quality System policies, programs, rules, and practices, including but not limited to product and patient safety, the health and safety of all associates as well as the environment and community at large.
• Will supervise a team of hourly production associates, which includes recommendations for discipline, termination, evaluations, etc.
• Performs other job-related duties assigned

Working Conditions/Physical Requirements

Knowledge, Skills and Abilities (KSA)

• Ability to direct and motivate staff
• Strong organizational skills
• Strong communication skills both verbal and written
• General knowledge of GMP requirements and ISO standards
• Some prior exposure to safety issues and good manufacturing practices
• Ability to solve problems daily regarding safety, quality, and productivity
• Ability to make decisions based on available production knowledge, maintenance and improvement plans, etc.
• Ability to work with hand tools and perform mechanical and minor electrical duties where knowledge of the task can be learned on the job.
• Makes production set-ups, changeovers to different products’ operations, adjustments and simple machine repairs to facilitate production.
• May be required to drive a forklift at certain times.
• Considerable standing, walking, lifting, etc.
• Must be proficient in Microsoft Excel, Word, PowerPoint, and Outlook

Qualifications/ Background Experiences

• High School diploma required, with advanced education preferred.
• Minimum of 4 years’ experience in manufacturing environment, which should include a minimum of 2 years’ experience in medical device or other similar regulated industry
• Minimum of 2-3 years supervisory experience preferred
• Supervisory experience in medical device or other similar regulated industry preferred

It is Terumo’s policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment.

Final compensation packages will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand. We provide competitive and comprehensive benefit options which include: annual bonus, paid vacation, paid holidays, health, dental and vision benefits, 401(k), with matching contributions, tax advantage savings accounts, legal plan, voluntary life and AD&D insurance, voluntary long-term disability, short term disability, critical illness and accident insurance, parental leave, personal leave, tuition reimbursement, travel assistance, and an employee assistance program. Rate of pay: $75,000 - $90,000/year