Job Title: NPD Systems Engineer II
Job Description

The NPD Systems Engineer II is responsible for ensuring a structured and interdisciplinary development approach for product systems from concept to production. This role considers both the business and technical needs of all customers to provide a quality product that meets user needs. As the technical conscience of the project, the NPD Systems Engineer II ensures the product design intent is maintained throughout the project. The role involves collaboration across all NPD projects to create a consistent approach and support.The NPD Systems Engineer II will represent the NPD Product Integrity group on a complex multi-discipline new product development project or multiple smaller projects. This role identifies technical risks, challenges design decisions, and bridges the gap between functional elements of the product development process. Responsibilities include defining customer needs and required functionality early in the development cycle, documenting requirements, leading human factors/usability activities, and progressing with design synthesis and system validation.Key responsibilities include providing cross-functional leadership, coordinating with various departments and external partners, troubleshooting systems-level issues, leading clinical testing activities, and ensuring cost viability throughout the project duration. The role also involves defining test plans, performing testing, analyzing results, and documenting conclusions in technical reports that may be submitted to the FDA.

Hard SkillsBS in Engineering (Mechanical, Electrical, or similar technical field)3 or more years of experience with product and understanding design controlsExperience in an FDA regulated industry, medical device or pharmaceuticalHands-on experience understanding of product development life cycleSolidWorks experience preferredKnowledge of test method developmentSoft SkillsCross-functional leadershipCollaborationTechnical risk identificationProblem-solvingClear and complete documentationJob Type

This is a Contract-to-Hire position with a duration of 9 Month(s).

Work Site

This is a hybrid position requiring some days on-site in Elkton, Maryland and some days remote.

Work Environment

New product development and high volume manufacturing environment. The facility spans 000 square feet and handles 10 products with different SKUs and sizes, including vascular access, closure, catheters, embolics, etc. Examples include high-volume products like vascular closure devices.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.