Global R&D Product Compliance Tech Lead

Global R&D Product Compliance Tech Lead

Date : Aug 20, 2024

Location : Lakewood, CO, US

Requisition ID : 32600

At Terumo Blood and Cell Technologies, our 7,000+ global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world.

For Terumo, for Everyone, Everywhere.

We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells.

With our innovative technologies and service offerings, we touch a patient’s life every second of every day and are committed to continuing to increase the number of patients we serve.

Advancing healthcare with heart.

With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference.

Join us and help shape wherever we go next. You create your future and ours.

JOB SUMMARY

R&D Technical Lead accountable for driving on time and on budget project execution within the R&D product portfolio. Develops and maintains in-depth knowledge of complex products and systems.

Performs duties that require application of intensive and diversified knowledge of engineering principles and practices in broad areas of assignments and related fields.

Responsible for ensuring that the organization complies with regulations guiding product manufacturing, packaging, safety, and quality.

ESSENTIAL DUTIES

• Plan and execute ongoing testing and compliance database for Global TBCT, collect and maintain evidence of legislative compliance, research ECHA-SCIP database submissions, recommend actions required to maintain compliance of active products.
• Research and communicate safety and compliance requirements relating to current products, new product categories, and expansion of sales to new regions.
• Monitor SVHCs used, respond to requests for SVHC information.
• Monitor RoHS exemption status of components.
• Partake in product development projects to ensure that safety, regulatory, and agency requirements are recognized and satisfied in target markets.
• Take part in Product Quality Risk Assessments projects to spot and quantify safety and compliance risks and develop mitigation plans.
• Ensure that safety and compliance requirements are met in aspects of a product such as labeling, packaging artwork, and instruction booklets.

Assist in Product Life Cycle Management efforts.

• Continuous improvement projects to ensure that product safety and compliance is maintained.
• Support the investigation and problem-solving for safety or compliance issues.
• Contribute to policies and processes to assure safety and compliance.
• Lead and direct internal product teams leadership and cross-functional teams on compliance-related issues.
• Direct one or more major phases of complex engineering work, utilizing engineering skills to devise entirely new approaches to problems encountered in projects.
• Develop new processes that have a significant impact on multiple disciplines.
• Contribute to the establishment of business objectives, goals, budgets, and costs as requested.
• Present complex technical information / analysis and respond to questions from technical staff members and management regularly and effectively.
• Identify and facilitate technical ROI tradeoffs and minimum viable functionality with commercial partners to meet customer needs as quickly and efficiently as possible.
• Provide broad-based direction for subordinates and colleagues within functional area and cross-functionally.
• Apply technical expertise to complex tasks with in-depth knowledge of related work areas.
• Employ in-depth knowledge of cross-functional and related technical areas, applying knowledge to other areas.
• Display accessibility and sought out for consultation on a broad range of complex technical and industry issues engineering staff and management.
• Work on complex issues where analysis requires an in-depth evaluation of variable factors. Exercise judgment in selecting methods, techniques, and evaluation criteria for obtaining results.
• Keep updated on recent technical advances within the industry and apply this knowledge to products and processes.

OTHER DUTIES AND RESPONSIBILITIES

• Work direction responsibility may include technicians and junior engineers.
• Communicate effectively with a wide variety of cross-functional partners including marketing, regulatory, quality, engineering, and scientific groups (both verbally and in writing) on a broad range of complex issues.
• Assist with product support escalations, including technical analysis and characterization of issues, and identification of workarounds and design improvements.
• May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues.
• May contribute to the establishment of business objectives, goals, budgets, and costs.

MINIMUM QUALIFICATION REQUIREMENTS

Education

• 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 or Master of Science degree in Engineering preferred.

Experience

• Minimum 4 years experience.
• Two years of GMP manufacturing experience required.

Skills

• Requires demonstrated skills in technical innovation, technical leadership, mechanical or materials engineering.
• Demonstrated interactive skills in, cross-functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, coordination with cross-functional team members, team behavior, and support for subordinates, junior engineers, technicians, and management.
• Represents the organization as the prime technical contact on projects. Interacts with senior-level external personnel on significant technical matters often requiring coordination between organizations.
• Follows and develops technical specification requirements and provides significant input on technical procedures on various processes that impact multiple disciplines.
• Knowledge and ability to implement FDA or regulatory requirements as necessary.
• Driver for acquiring resources and building consensus across products.
• Solicits and accepts the ideas of others, as well as actively contributes to an environment conducive to open communication.
• Regularly and effectively presents complex technical information / analysis, and responds to questions from technical staff members and management.
• Understanding of and adherence to GMP practices and FDA regulations.
• Demonstrated ability to communicate effectively both verbally and in writing.
• Knowledge and use of relevant PC software applications and skills to use them effectively.

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

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.

Additional Physical Requirements

Requires travel based on business needs.

Target Pay Range : $107,000.00 to $133,800.00 - Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data

Interested in this role You can find all the relevant information in the description below.

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.

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