Principal Engineer - Design - Defined Term

Getinge•Arvada, CO

57d•Onsite

About The Position

With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career? You just found it. Steritec Products Inc., a member of the Getinge Group, manufactures sterilization and cleaning medical device consumables using ink technology. We manufacture and print highly specialized proprietary inks that undergo specific color changes when exposed to different sterilization conditions in hospital and industrial/pharmaceutical sterilizers. We are located in the beautiful Inverness Business Park in Englewood, CO. We offer a generous benefit package (medical, dental, vision, life, 401(k) as well as company-paid holidays) all effective first day of employment! This is a Fixed Term assignment that is slated to run through December 2026. The Principal Engineer – Design position is an on-site, full-time position. Hours are Monday – Friday, 8:00am – 4:30pm (with some flexibility). Job Function Summary:This position will be primarily responsible the design of consumables products and automation in a quality systems FDA and ISO 13485 regulated environment. The Principal Engineer - Design will play a key role in the design and process development of patient-centric, safe, reliable, and innovative devices. The Principal Engineer – Design will report directly to Director, Research and Development and will be working both independently and in the R & D team. Duties will include creating complete Design History file, risk management file, prototype development, Design for manufacturing, Sustaining engineering and testing/validation of products and automated solutions for production. All steps in the design phase of the products are required to be properly documented in accordance with local and corporate procedures. Principal Engineer - Design is responsible for safe handling of chemicals and control of hazardous waste.

Requirements

Bachelor’s degree in Engineering or equivalent work-experience required.
The person in this position will need to think outside the box, be confident in their abilities, and carry out design projects autonomously as assigned.
Previous medical device development experience, preferably with both consumables/single use and capital equipment market segment.
Minimum of 10 years of experience as a product development engineer in Medical device development.
Extensive Knowledge of medical device development, equipment and process qualification, automation, and Good Manufacturing Practices.
Full Product development lifecycle experience for medical devices.
Proven track record of previous engineering development projects.
Ability to read, interpret and test according to ISO/FDA standards and guidance documents and convert them to Requirements for product compatibility.
Verification and Validation test development experience.
Need to possess excellent computer skills in: o Microsoft Office o SolidWorks

Nice To Haves

Master’s degree in Engineering preferred
Knowledge of the regulatory and compliance requirements of device and products design controls and manufacturing in US/ROW.
Experience in multiple sterilization modalities is highly desirable.
Experience in electrical and/or mechanical automation engineering is preferable.
Knowledge of Capital equipment and consumables.

Responsibilities

Works with the R&D team in achieving product development objectives and goals in a timely manner.
Creates innovative solutions aligned to the User needs and requirements of products. Makes basic decisions that involve direct application of technical knowledge and performs work in a structured environment under direction from R&D Director.
Creates Design and development plan with R&D team to achieve requirements. Analyzes results of experiments, information and standard practices using established protocols and methodologies to solve problems.
Follow design controls and procedures.
Follows the NPD Stage Gate Process and R & D Operating Model for new development projects.
Independently leads projects and design and development activities with R&D team.
Responsible for assisting in mentorship and training of junior engineers.
Responsible for the development of automation, scale up, and validation of equipment as necessary. Required to be a contributing member of validation teams and the development manufacturing processes in an FDA regulated environment using current Good Manufacturing Practices.
Tests equipment and products to ensure conformance to FDA and ISO regulations.
Conducts work on site in compliance with all quality and safety rules and regulations.
Trains Quality Control and Research & Development technicians on equipment as necessary.
Build Quality into all aspects of work.
Ensure compliance to all FDA and ROW Quality & Compliance regulations.
Attend all required Quality & Compliance training as specified.
Adopt the “Beyond Compliance Quality Culture” in the work environment; always meet and exceed requirements.
Must practice verbatim compliance (exact compliance, no interpretation) with corporate Quality and Regulatory procedures.
Must be able to promptly report any non-compliance issues to Director QA, RA, Compliance officer or appropriate administrator, including the Compliance Hotline.
The Principle Engineer - Design will be exposed to significant amount of the corporation’s intellectual property. Good control of documents and discretion is required.
Responsible for understanding and conforming to the Environmental Policy to ensure that significant environmental aspects that relate to actual or potential impacts with their work are executed to minimize the effects on the environment.
Responsible for bringing to the attention of management any potential improvements that could reduce our environmental impact or to report activities that could result in a negative impact to the environment.
Responsible for understanding and conforming to the Health and Safety Policy to ensure that the significant risks that relate to actual or potential hazards with their work are identified.