Engineer 2 - Mechanical

Terumo BCT, Inc.•Denver, CO

1d•$86,400 - $108,000•Onsite

About The Position

As a Mechanical Engineer 2 at Terumo, you’ll take a hands-on role in developing new medical devices, from early concept through design verification and transfer to manufacturing. Working with more independence than an early-career engineer, you’ll own the mechanical design of assigned subsystems, make sound engineering decisions on moderately complex problems, and help guide junior engineers along the way. You’ll work across R&D, quality, regulatory, and manufacturing to turn design concepts into products that meet performance, safety, and regulatory requirements. The systems you help create are used by clinicians and blood center teams to collect, process, and deliver the blood- and cell-based therapies that patients depend on.

Requirements

Bachelor of Science degree in Mechanical Engineering is required.
Relevant internship or project experience in mechanical engineering, preferably with a focus on medical device development.
Ability to solve moderately complex technical problems, make sound design decisions, and execute with minimal supervision.
Strong CAD design skills (e.g., SolidWorks) and experience with PLM/PDM systems, with Windchill preferred.
Experience taking mechanical designs through development, verification, and transfer to manufacturing.
Working knowledge of design controls, risk management, and medical device regulations and standards (e.g., FDA, ISO 13485, IEC 60601).
Familiarity with manufacturing processes such as machining, 3D printing, and molding, and how they shape design choices.
Knowledge of engineering analysis methods, statistical tools, and continuous improvement techniques.
Project management skills covering scope, schedule, cost, and deliverables.
Clear written and verbal communication, including presenting technical information to audiences up to senior management.
Ability to guide technicians and junior engineers and collaborate across functions and locations.
Initiative, curiosity, and ownership, with adaptability in a fast-paced, regulated environment.
Must either have a current passport or be eligible to obtain a passport and US Visa.

Nice To Haves

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

Responsibilities

Lead the mechanical design of assigned components and subsystems for new products, from concept through detailed design, applying sound engineering judgment to complex technical decisions.
Develop and evaluate design concepts using engineering analysis, modeling, and prototyping to test feasibility and guide design decisions.
Plan and carry out mechanical characterization, verification, and validation at the component and system level to confirm products meet performance and safety requirements.
Apply design controls and risk management throughout development, identifying and mitigating mechanical safety risks across the product lifecycle.
Support design transfer to manufacturing, working with operations to make designs manufacturable, repeatable, and ready for production.
Evaluate, select, and adapt engineering techniques and new mechanical technologies to develop innovative, reliable designs.
Manage project responsibilities such as scope, schedule, cost estimates, and execution for assigned design work.
Prepare and review engineering deliverables, including reports, SOPs, protocols, design changes, drawings, schedules, and supplier documentation.
Develop reports, charts, and analyses to support design recommendations, and present findings to cross-functional teams and technical leadership.
Provide technical guidance to technicians and junior engineers, and collaborate across R&D, quality, regulatory, and manufacturing.
Apply FDA and other regulatory requirements, supporting Quality System and Design Controls with particular attention to documentation.