Remote Mechanical engineer Jobs in Coral Springs, FL

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 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

www.terumoaortic.com

Job Summary

Evaluate and ensure manufacturing engineering operations can have a steady and robust supply of all components required to maintain daily production. This includes planning and implementing any work necessary to address supplier changes to efficiently implement and sustain supply.
to produce products and develop processes to ensure quality, cost, and efficiency requirements. This also would include projects required to implement regulatory changes and/or development of alternate critical suppliers to ensure continuous supply. Lead and manage key process items to bring reduce overall product/component cost and improve efficiency of manufacturing operations.

Job Details/Responsibilities

• Ensure suppliers are assessed and highest risks are identified and addressed to ensure the most robust component supply possible.
• Develop strong relationships with TAS suppliers and support any changes in an efficient and collaborative manner.
• Ensure new suppliers are robust and financially viable for projected long term growth including support in product development, validation planning, design for manufacturability and assembly, Design of Experiments, process capability analysis, etc.
• Lead the conversion of small-scale processes into commercially viable large-scale operations.
• Lead DOEs, TMVs and software validation as necessary
• Support Quality system items such as CAPAs, NCRs, CQPs, TMVs, etc.
• Recommend modifications/improvement where advisable to minimize cost.
• Provide primary direction for Quality System implementation, maintenance, training, and facilitation for compliance to quality system requirements for manufacturing and engineering staff.

Job Responsibilities (continued)

Working Conditions/Physical Requirements

QUALITY REQUIREMENTS:

• Maintain awareness of the relevance and importance of activities performed and how they contribute to the achievement of quality objectives.
• Work within the QMS always, ensure accurate completion of records and highlight issues to immediate supervisor any issues affecting quality.
• Responsible to ensure facility, processes and documentation always remain in a state of audit readiness.

EH&S REQUIREMENTS:

• Take care of your own health and safety and that of others who maybe affected by your actions.
• Work co-operatively to highlight issues affecting Environmental Health and Safety

Knowledge, Skills and Abilities (KSA)

• Excellent written and verbal communication
• Understanding of quality system (ISO13485, 21CFR820) regulations
• Strong leadership skills
• Ability to interact with all levels within organization.
• Ability to delegate and motivate subordinate staff.
• Analytical skills for compiling and analyzing data.
• Computer and software skills
• Understanding of supply chain activities
• Problem solver able to think analytically.

Qualifications/ Background Experiences

• 4 - year engineering degree or equivalent experience
• 7+ years of experience in a technical role in the medical device industry
• Project management experience in the medical device industry
• Experience and understanding of quality system regulations (e.g. 21CFR820, ISO13485).
• 5 years of medical device manufacturing
• Statistical and process controls experience, including experience with Design of Experiments, qualifications, and validations.

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.