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Terumo Blood and Cell Technologies · 2 weeks ago

Engineer 3 - Global Supplier Quality

Lakewood, CO

Full-time

Hybrid

Mid Level

$106K/yr - $132K/yr

4+ years exp

Terumo Blood and Cell Technologies is a leading company in the medical devices industry, dedicated to impacting patient lives globally. The Engineer 3 - Global Supplier Quality Engineer will work with suppliers to resolve quality issues and improve process reliability, focusing on technical report writing, CAPA investigations, and project management.

Medical Device

H1B Sponsor Likely

Responsibilities

Functions as a member of the Global Supplier Engineering Team working cross-functionally and proactively on supplier quality and management activities. These activities include:

Extrusion troubleshooting

Component, tooling, and process validations / verification with technical reports

Project management of supplier quality initiatives

Corrective and Preventative Action (CAPA)

Highlights risks and understands how to approach and complete tasks, avoiding serious delays and considerable expenditure of time and resources

Perform independent evaluation, selection, and application in making adaptations and modifications to projects

Receives assigned total project leadership responsibilities on a portion of major significant projects and will be given total management responsibility for smaller projects

Manages and provides leadership for the functional group’s development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives

Understands FDA or regulatory requirements as necessary

Applies technology principles to multiple tasks. Working knowledge of cross-functional and related technical areas

Advises team members pro-actively on technical ideas and promotes skill development of teamwork

Interacts with peers across projects to secure resources and commitments

Handles frequent inter-organizational and outside customer contacts. Represents the organization in providing solutions to difficult technical issues associated with specific projects

Follows technical specification requirements and provides feedback on various technical processes and procedures

Presents effectively complex technical information/analysis and responds to questions from technical staff members and management

Works cooperatively and effectively within a team environment to achieve common goals and results, often influencing the outcome of the team(s)

Work direction responsibility may include technicians and junior engineers

May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues

Performs ISO 13485 and or ISO 9001-based audits of suppliers and conducts other assessments of supplier capability

Qualification

Process validationGMP manufacturingProject managementCAPA investigationsFDA regulationsTechnical report writingMechanical engineeringChemical engineeringFluids engineeringCellular biologyPC software proficiencyTechnical leadershipCommunication skills

Required

Bachelor's degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered

Bachelor of Science Degree in Engineering, preferred

Minimum 4 years experience

Two years of GMP manufacturing experience required

Requires demonstrated skills in technical innovation, technical leadership, mechanical and or chemical engineering, fluids engineering, and cellular biology

Strong interactive skills in general communication, cross-functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, coordination with cross-functional team member, team behavior, and support for subordinates, junior engineers, technicians, and management

Strong technical problem-solving skills

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

Knowledge and use of relevant PC software applications and skills to use them effectively

Benefits

Multiple group medical, dental and vision plans

A robust wellness program

Life insurance and disability coverages

A variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance

401(k) plan with a matching contribution

Vacation and sick time programs for associates

Company

Terumo Blood and Cell Technologies

Glassdoor3.4

Headquartered in Lakewood, Colorado, Terumo Blood and Cell Technologies is a global leader in blood component, therapeutic apheresis and cellular technologies serving customers in more than 150 countries.

Founded in 1964

Lakewood, Colorado, US

5001-10000 employees

http://www.terumobct.com

H1B Sponsorship

Terumo Blood and Cell Technologies has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (14)

2024 (7)

2023 (8)

2022 (8)

2021 (8)

2020 (7)