Engineer 2 - Systems Engineering

Requisition ID: 35079 Systems Engineer Level 2 Job Summary Performs duties that require application of intensive and diversified knowledge of engineering principles and practices in broad areas of assignments and related fields. Assesses impact of design changes on product functionality/quality. Evaluates and develops plans, requirements, and associated criteria for a variety of products, and design activities. Carries out complex or novel research assignments requiring the development of new or improved systems engineering techniques and procedures. This position represents the function of Systems Engineer as a team member on development projects. The Systems Engineer develops, performs, reviews, and approves work required to deliver quality product designs per customer and business expectations following the design controls process. Participates and contributes to regulatory submissions and audits across a global customer base. Understands, provides direction, and adheres to Design Controls procedures. Ensures customer and regulatory requirements are upheld in accordance with business needs. Essential Duties Leads, contributes to, and is accountable for new and/or updated product design projects. Performs, and supports design controls activities and deliverables. Guides the successful completion of design control deliverables for major programs and may function in a project leadership role. Directs one or more major phases of complex engineering work, utilizing engineering skills to devise efficient approaches to design and other problems encountered in projects. Develops, and/or tests new design processes/tools that have a significant impact on multiple disciplines. Contributes to the establishment of business objectives, goals, budgets and costs as requested. Presents complex technical information/analysis, and responds to questions from technical staff members and management regularly and effectively. Provides broad-based direction for colleagues within functional area and cross functionally. Applies technical expertise to complex tasks with in-depth knowledge of related work areas. Displays accessibility and is sought out for consultation on a broad range of complex technical and industry issues. Works on complex issues where analysis requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results. Other Duties and Responsibilities Work direction responsibility may include technicians and junior engineers. 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. Medical device product development experience preferred. Systems Engineering (in-depth understanding of how hardware, software, and disposables interact in a systematic way) preferred. Customer interaction experience preferred. Skills 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 and other 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. 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 Target Pay Range: $86,400.00 to $108,000.00 – Salary to be determined by education, experience, knowledge, skills, and abilities of the applicant, internal equity, and market data. Target Bonus on Base: 7.0% Benefits Competitive total reward offerings including compensation, benefits, recognition, wellness programs, life insurance, disability coverage, and voluntary programs. 401(k) plan with matching contribution. Vacation and sick time programs. Robust wellness program and other well‑being initiatives. We are proud to be an Equal Opportunity Affidavit 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. #J-18808-Ljbffr