Responsible for providing engineering support in the creation and the development of new Division products.
Requirements
Bachelor’s Degree (BS) in Engineering, Master’s (MS) Preferred.
10+ years’ experience in mechanical engineering or product development.
Ability to work within many functions and support the Electrical, Mechanical and Systems development teams.
Demonstrated mastery of CAD modeling and drawing creation (Solidworks or equivalent)
Ability to work on-site full-time.
Nice To Haves
Demonstrated ability to understand and comply with applicable FDA regulations and Company operating procedures, processes, policies and tasks.
Multitasks, prioritizes, and meets deadlines in timely manner.
Strong organizational and follow-up skills, as well as attention to detail.
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
Detailed knowledge of FDA, GMP, and ISO 13485.
Responsibilities
Researches, develops, designs, and evaluates mechanical and electro-mechanical materials, components, assemblies, processes and/or equipment.
Ownership of large electro-mechanical assembly product design and development.
Conducts feasibility studies to verify capability and functionality.
Develops new concepts from initial design to market release with a strong understating of GD&T.
Directs support personnel and coordinates project activities.
Maintains detailed documentation throughout all phases of research and development.
Investigates and evaluates existing technologies.
Reviews or coordinates vendor activities to support development.
Utilizes simulation and modeling tools to direct and evaluate designs.
Understands business environment and relates extensive knowledge of internal and external technological activities to trends.
Interfaces with senior management on significant matters, often requiring the coordination of activity across organizational units.
Participates in the development of other technical contributors by facilitating training and providing feedback and guidance.
May lead a project team.
Acts as a mentor to less-experienced staff and may provide work direction or supervise other technical employees.
Exercises judgment independently.
Plans and organizes project assignments of substantial variety and complexity.
Initiates or maintains schedule for projects and project milestones.
Establishes priorities of individual or project assignments.
Selects methods and techniques to lead a project to completion.
Erroneous decisions or recommendations would typically result in failure to achieve major organizational objectives.
Benefits
Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
An excellent retirement savings plan with a high employer contribution.
Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.