Engineer 2 - New Product Introduction

Requisition ID : 32248

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.

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.

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.

Consider joining our team and unlock your potential.

This position is on the New Product Introduction team that works with Research and Development and Manufacturing teams on process development and design transfer for new disposables and equipment products.

Work requires independent evaluation, selection and application of standard engineering techniques, procedures, and criteria, using judgment and ingenuity in making minor adaptations and modifications.

Assignments include equipment design and development, tests of materials, preparation of specifications, process study, research investigations, report preparation and other activities of limited scope.

Duties are assigned to provide experience and familiarization with engineering methods, independent thinking, and company practices and policies.

ESSENTIAL DUTIES

• Performs research, design, and development of manufacturing processes including production flow, assembly methods, and production equipment.
• Supports the manufacturing launch of new / revised products including establishing goals, training team members, and evaluating results.
• Designs, implements, and validates high performing processes that assure product quality.
• Partners with Design Team to understand product requirements and supports Design for Manufacturability initiatives.
• Analyzes processes through quality improvement methodologies and the use of statistical tools.
• Manages projects including development of project scope and estimates, initiation of requests for capital when required, specification of equipment and installation requirements, management of costs to budget, and support of IQ / OQ and final documentation in accordance with acceptable engineering practices.
• Prepares and reviews engineering / technical documents such as reports, SOP’s, protocols, schedules and budgets, and vendor provided documents and drawings.
• Ensures that process and equipment designs are compliant with all Company policies and procedures as well as all Local, State, and Federal directives, laws and regulations.
• Provides work direction to engineering support staff.
• Takes initiative and demonstrates inquisitive approaches to solve moderately complex problems, indentifying problems, generating alternatives and recommending solutions.
• Follows department processes and regularly makes recommendations on these processes.
• Follows technical specification requirements, developing reports, charts and graphs to support project recommendations and responds to questions from technical staff members and management.
• Work assignments may require additional development and a maturing or broadening of in-depth engineering skill(s).
• May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues.

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 in Engineering, preferred.

Experience

• Minimum 2 years experience.
• Two years of GMP manufacturing experience required.

Skills

• Understands manufacturing and test equipment concepts, technologies, and techniques and how to apply them to improve quality and efficiency.
• Experience with manufacturing processes such as electromechanical assembly, RF welding, ultrasonic welding, injection molding, and solvent bonding preferred.
• Experience with Solidworks and Minitab preferred.
• Requires interactive skills in cross-functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, coordination with cross-functional team members including global manufacturing teams, team behavior, provides support for subordinates, junior engineers, technicians, and management.
• Mechanical and electronic ability and aptitude to assist with equipment trouble-shooting.
• Interfaces with staff, suppliers, and external subject matter experts to resolve technical issues and train and provide 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.
• 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.

LOCATION

Lakewood, Colorado - 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 $102,500.00 - 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.
30+ days ago