Manager, Sustaining Engineering

Terumo Cardiovascular Group; Town of Florida (NY); On-site; USD 120,000 - 160,000; Full time

Job summary

Terumo Cardiovascular Group in the Fort Lauderdale/Miami area seeks a Manager, Sustaining Engineering to lead the Sustaining Engineering group, drive post-release design changes and ensure regulatory compliance. You will oversee performance plans, budgets and cross-functional interactions with manufacturing and quality teams.

The role requires a BS in Engineering with 7 years in medical device development, plus strong leadership and V&V expertise.

Qualifications

• BS in Engineering or related technical field with 7 years of Medical Device product development experience.
• Understanding cross-functional activities needed for design control and transfer to manufacturing.
• Ability to manage design changes and assess V&V activities related to form, fit, function, and performance.
• Experience developing budgets and leading an engineering group.

Responsibilities

• Provide direct supervision, development and performance planning for the Sustaining Engineering group; prepare IDPs and conduct reviews.
• Lead change order activities related to product design changes, supporting team and schedule.
• Ensure existing products remain compliant to new and existing standards.
• Develop or hire SME expertise in design control and product design changes.
• Develop budgetary estimates and manage the Sustaining Engineering budget.
• Prepare presentations and present project updates to senior management.
• Perform other duties as assigned.

Skills

Medical Device Development

Regulatory Compliance

Cross-functional Leadership

Budgeting

V&V (Verification & Validation)

Design Change Management

Team Leadership

Education

BS in Engineering

Job description

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At Terumo Aortic, our mission is to transform the treatment of aortic disease worldwide. With our comprehensive portfolio of surgical, endovascular and hybrid technologies, we enable physicians to find the right fit for each patient anatomy.

The company has over 1,250 associates around the world with manufacturing facilities in Glasgow, Scotland and Sunrise, Florida.

Terumo Aortic is focused on the continuing development of new and innovative products driving the growth of the business globally. Associates are part of a stimulating and exciting environment in which they can develop their skills and achieve career goals. Working for the company, each associate’s role contributes greatly to helping to save or improve the lives of patients in over 100 countries worldwide.

At Terumo we believe in the power of personal growth and will encourage you to get 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!

The Manager, Sustaining Engineering position is responsible for the organizational development, functional management and performance of the Sustaining Engineering group with direct supervisory, development and performance planning responsibilities for the engineering and technical personnel within Sustaining Engineering group.

The Manager, Sustaining Engineering will be accountable for managing post-release product changes relating to form, fit, function, or performance that relate to product requirements changes such as potentially affecting device usability, dimensional, material, or regulatory standards.

• Responsible for the organizational development, functional management and performance of the Sustaining Engineering group. This includes providing direct supervision, development and performance planning to engineering and technical personnel within the Sustaining Engineering group; prepare Performance Plans, Individual Development Plans (IDPs) and conduct mid- and full year Performance Reviews with associates.
• Accountable for leading and driving change order activities related to product design changes, the team supporting the change, and schedule.
• Accountable for ensuring existing products remain compliant to all new and existing standards
• Accountable for developing or hiring technical SME expertise in design control and product design changes.
• Develop budgetary estimates and be responsible for the Sustaining Engineering departmental budget.
• Prepare presentations and formally present project updates and reviews to senior management.
• Performs other duties as assigned.
  

Job Responsibilities (continued)

Working Conditions/Physical Requirements

Knowledge, Skills and Abilities (KSA)

• Extensive experience in the development of global Medical Devices in accordance with global regulatory and quality standards and requirements.
• Demonstrated understanding of the cross-functional interactions needed for the development and change management of products within medical device industry design control guidelines
• Effective communication skills, both verbal and written.
• Ability to develop budgetary estimates and manage their execution.
• Functional management and organizational development experience in managing an Engineering group and in preparing Performance and Development Plans and reviews.
• SME understanding of design and verification and validation (V&V) approaches.
  

Qualifications/ Background Experiences

• BS in Engineering or other related technical field with 7 years of Medical Device product development experience.
• Demonstrated understanding of the roles and responsibilities of the cross-functional activities needed to successfully develop new and transfer existing products to manufacturing and release for commercialization.
• Demonstrated ability to manage design changes and assess engineering V&V activities related to product form, fit, function, and performance
  

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 may be higher or lower than what is listed, and 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.

Nearest Major Market: Fort Lauderdale
Nearest Secondary Market: Miami