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Manufacturing Process Engineer

2 months ago


Lakewood, United States Terumo BCT Full time

Requisition ID: 32248

At Terumo Blood and Cell Technologies, our 7,000+ global associates take pride in their work, knowing that our contributions significantly impact patients' lives worldwide.

We specialize in creating medical devices and related products that facilitate the collection, separation, manufacturing, and processing of various blood and cell components. Our innovative technologies and services positively influence patient care every second of every day, and we are dedicated to expanding the number of patients we assist.

With a team comprising some of the industry's brightest minds, an unmatched global presence, comprehensive benefits, and a unique culture, Terumo Blood and Cell Technologies offers an excellent environment for professional growth and teamwork focused on making a meaningful difference. We invite you to consider joining our team and unlocking your potential.

This role is part of the New Product Introduction team, collaborating with Research and Development and Manufacturing teams on process innovation and design transfer for new disposable and equipment products. The work necessitates independent assessment, selection, and application of standard engineering techniques, procedures, and criteria, utilizing judgment and creativity in making minor adjustments and modifications. Responsibilities include equipment design and development, material testing, specification preparation, process analysis, research investigations, report writing, and other activities of limited scope. Assignments are designed to provide experience and familiarity with engineering methodologies, independent thought, and company practices and policies.

KEY RESPONSIBILITIES

  • Conducts research, design, and development of manufacturing processes, including production flow, assembly techniques, and production equipment.
  • Facilitates the manufacturing launch of new or revised products, establishing objectives, training team members, and assessing outcomes.
  • Designs, implements, and validates high-performance processes that ensure product quality.
  • Collaborates with the Design Team to comprehend product requirements and supports Design for Manufacturability initiatives.
  • Evaluates processes using quality improvement methodologies and statistical tools.
  • Manages projects, including defining project scope and estimates, initiating capital requests when necessary, specifying equipment and installation needs, managing costs within budget, and supporting IQ/OQ and final documentation in line with acceptable engineering practices.
  • Prepares and reviews engineering and technical documents such as reports, SOPs, protocols, schedules, budgets, and vendor-provided documents and drawings.
  • Ensures compliance of process and equipment designs with all Company policies and procedures, as well as local, state, and federal regulations.
  • Provides guidance to engineering support staff.
  • Takes initiative and demonstrates inquisitive approaches to resolve moderately complex issues, identifying problems, generating alternatives, and recommending solutions.
  • Adheres to departmental processes and regularly suggests improvements.
  • Follows technical specification requirements, developing reports, charts, and graphs to support project recommendations and addressing inquiries from technical staff and management.
  • Work assignments may necessitate further development and enhancement of in-depth engineering skills.
  • May collaborate with manufacturing and other functional groups on manufacturing and regulatory compliance matters.

MINIMUM QUALIFICATIONS

Education

  • Bachelor's degree or equivalent education and experience sufficient to successfully perform the essential functions of the job may be considered.
  • Bachelor of Science Degree in Engineering is preferred.

Experience

  • A minimum of 2 years of experience is required.
  • Two years of GMP manufacturing experience is mandatory.

Skills

  • Comprehends manufacturing and testing equipment concepts, technologies, and techniques, and applies them to enhance quality and efficiency.
  • Experience with manufacturing processes such as electromechanical assembly, RF welding, ultrasonic welding, injection molding, and solvent bonding is preferred.
  • Familiarity with Solidworks and Minitab is advantageous.
  • Requires interactive skills for cross-functional participation and influence, mentoring, and acceptance of guidance, technical leadership, project management, and coordination with cross-functional team members, including global manufacturing teams.
  • Mechanical and electronic aptitude to assist with equipment troubleshooting.
  • Interacts with staff, suppliers, and external subject matter experts to resolve technical issues and provide training and work direction to operators and production service technicians.
  • Understanding of and adherence to GMP practices and FDA regulations.
  • Knowledge and ability to implement FDA or regulatory requirements as necessary.
  • Demonstrated ability to communicate effectively both verbally and in writing.
  • Proficient in relevant PC software applications and skills to utilize them effectively.

-Or-

An equivalent competency level acquired through a variation of these qualifications may be considered.

LOCATION

Open to candidates willing to relocate to the area.

Travel

Requires travel based on business needs.

PHYSICAL REQUIREMENTS

  • General Labor Environment requirements include: use of personal protective equipment, reading, speaking, hearing, walking, bending, standing, stretching/reaching, hand/finger dexterity, and occasional lifting up to 50 pounds, or transporting up to 500 pounds via carts or mechanized equipment.
  • The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

Target Pay Range:$82,000.00 to $102,000.00, Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data.

Target Bonus on Base:7.0%

At Terumo Blood and Cell Technologies, we provide competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life, and recognition programs which support in unlocking the potential for you and your family. Included in our expansive list of benefits offerings are multiple group medical, dental, and vision plans, a robust wellness program, life insurance and disability coverages, also a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance, and much more. To help you save for retirement, we offer a 401(k) plan with a matching contribution and for work-life balance, we have vacation and sick time programs for associates. For us, it's about protecting the personal welfare of our associates and their families, helping to achieve personal goals and offering those extra touches for convenience, security, and overall peace of mind.

  • Terumo Blood and Cell Technologies is part of Terumo Group, founded in 1921 and headquartered in Tokyo, Japan.
  • In 2019, Terumo Blood and Cell Technologies reached $1 billion in revenue.
  • We employ nearly 7,000 associates globally, with global headquarters in Lakewood, CO, U.S., and regional headquarters in Brussels, Buenos Aires, Singapore, and Tokyo.
  • We manufacture devices, disposable sets, and solutions at our facilities in Belgium, India, Japan, Northern Ireland, the U.S., and Vietnam. Our global presence enables us to serve customers in more than 130 countries.
  • Our core values help set our direction, guide our actions, and keep us true to our corporate mission of contributing to society through healthcare.
    • Respect - Appreciative of others
    • Integrity - Guided by our mission
    • Care - Empathetic to patients
    • Quality - Committed to excellence
    • Creativity - Striving for innovation
  • We contribute to the Leukemia and Lymphoma Society (LLS), raising $1.3 million USD since 2007.

We are proud to be an Equal Opportunity Affirmative Action Employer. All applicants will be afforded equal opportunity without discrimination because of race, color, religion, sex, gender identity or expression, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status or an unfavorable discharge from military service.

Terumo Blood and Cell Technologies is committed to providing a safe, healthy, and secure working environment. Our Colorado campus locations are tobacco-free workplaces, and we maintain a drug-free workplace and perform pre-employment substance abuse testing and detailed background verification.