Manufacturing Engineer

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.

We believe that the future is bright for everyone at Terumo. We work with the future in mind to generate lasting change, create a bigger impact and produce greater outcomes for today, and for decades to come.

At Terumo we believe in the power of personal growth and will encourage you to get in the driver's seat - progressing in the direction you want to go by deepening your skills throughout your career. We want you to be bold, think outside the box, experiment, innovate and deliver what's next for quality healthcare. You will be part of a collaborative, respectful and resilient team of associates and leaders around the world, working together as partners to achieve more than you thought possible, providing real-world, impactful solutions for patients.

Join us and help shape wherever we go next!

Advancing healthcare with heart

Job Summary:

The Manufacturing Training Supervisor is responsible for participating in designing, developing, facilitating and executing training requirements for Terumo Medical Corporation’s (TMC) Manufacturing teams.  The objective of this training is to ensure compliance to cGMP, quality, regulatory and enterprise/corporate business requirements. At a minimum, this includes the FDA’s Quality System Regulation/Current Good Manufacturing Practices (21 CFR 820) and ISO-13485:2016. In addition, the successful candidate will participate in developing and facilitating objective measures for determining the effectiveness of the training content and successful learning of training objectives. The Manufacturing Training Supervisor will work with key business SME’s to develop, facilitate and maintain appropriate training for Manufacturing facility personnel.  The individual in this position must be a self-starter with experience in developing new and innovative business and medical device quality systems training programs from the conceptual stage.  The ideal candidate must also be able to perform primarily at a tactical level with some participation in strategic level activities.   This includes developing and facilitating a training schedule, curriculum, on the job training / proficiency qualification programs, records system and process for continuous improvement.  The overall business goal of the Manufacturing Training Supervisor is to support the development of a quality/business culture based upon effective compliance and continuous business improvement throughout TMC. 

Job Details:

• Develop and supervise a team of Manufacturing Trainers.  Provide coaching for professional growth and career development. 

• Establish an effective, efficient and compliant quality systems training program focused on the Manufacturing area.  This includes exempt and non-exempt personnel.
   
• Work with functional heads to develop and deploy a role-based Quality System training curriculum and the operations training infrastructure including on the job training and training proficiency qualification programs.
   
• Work with external training material providers to define, develop, implement and evaluate the required training materials, as needed.

• Develop and maintain the foundational training components of onboarding of new hires and train them or facilitate training on TMC Quality System policies and procedures.

• Oversee the proficiency qualification program to ensure all employees have appropriate training and maintain qualification in their roles.
• Work closely with Management and Engineering personnel to understand system and process changes and develop and maintain programs to ensure adequate transfer of knowledge during process creation or revision. 
• Develop a network of SME’s to create, review, evaluate and possibly deliver the required training content and materials necessary for effective Company compliance.
• Work with SME’s to develop measures for determining and documenting training effectiveness measures.
• Utilize the TMC electronic QS training system and assist with the development of an efficient training records maintenance process.
   
• Support the TMC Quality Systems training program during internal and external audits.
  

   

  Position Requirements:

   

  Knowledge, Skills and Abilities (KSAs)

   

• Strong computer knowledge (MS Office), technical writing skills and proofreading ability.
• Ability to shape a training program from conception.
• Ability to establish and maintain a structured training development process (such as the Define, Develop, Implement, Evaluate and Improve process).
• Working knowledge of managing multiple databases and Learning Management Systems (LMS’s) for a medical device and/or pharma environment.
• Ability to clearly communicate (both verbal and written), and successfully influence, all levels of the organization.
• Must have strong proofreading skills and organizational skills, as well as exemplary attention to detail.
   
• Must have demonstrated initiative and ability to work independently while handling multiple tasks. 
• Good theoretical knowledge of ISO standards (ISO 13485) and regulatory requirements (21 CFR 820 and related regulatory regulations).
• Proven ability to manage and motivate employees in a dynamic, evolving and growing business environment.

• Background Experience

   

• Position typically requires a 2-year degree or 4 years experience in a leadership role in a manufacturing or training capacity
• 2 years managing employees preferred.
• 3 years minimum training experience in a regulated industry.

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:  $73,000 - $110,000/year.