Senior Staff Mechanical Engineer

Education/Experience Required

1. Mechanical Engineering degree or related experience
2. Surgical or class 2 med device/instruments (handheld, surgical, or interventional instruments) with an understanding of clinician usability
3. Must have instrument or system-level design, more than component design. Responsible for more than a component, must own product design
4. Experience with concept development without very well-known specs. Must have front-end development, not just back-end
5. Med device product development (design control, etc.)
6. Fit- high energy, sense of urgency, risk-taking
7. Needs at least 8 years of experience, prefer more than 10
8. Experience with concept to manufacturing.
9. Need more experience than with well-established products, previously led a major redesign or new product from scratch

Our startup is developing a laparoscopic specimen removal system for minimally invasive surgery (MIS) designed to fully contain specimen segmentation and removal. We have secured ~$9M in financing from a Strategic Venture to fund U.S. regulatory and IDE clinical trial activities.

We are partnering with our VP of R&D to hire our Mechanical Engineering team (Senior and up).

These positions will be responsible for the mechanical design (mechanisms) and product development activities while adhering to all relevant medical device FDA standards and regulations related to handheld instruments. Additionally, showcasing a technical depth utilizing analytical tools and technical solutions directly solving problems will be a key focus for this role.

These positions will be technical leaders influencing processes and infrastructures with rapid potential for upward mobility within the organization.

Candidates must be within driving distance of company headquarters in Louisville, Colorado for these positions.

**Relocation assistance is available for the right candidates**

Duties and Responsibilities:

• Establishes, executes, and reports on product development deliverables.
• Conducts product testing, creates models, and prototypes, and provides constructive feedback to design engineers.
• Performs clinical and preclinical assessments.
• Conducts project management tasks & documentation with design controls and risk analysis in accordance with established SOPs.
• Incorporates required regulatory standards (FDA, ISO) in developmental and/or sustaining engineering projects including written protocols, test methods, assembly processes and the Design History File.
• Prepares reports, presentations and spreadsheets of an analytical and interpretative nature to be presented to peers, executives, surgeons, customers.
• Collaborates with peers to manage the development of appropriate testing to verify product meets internal and external customer requirements.
• Provides strategic vision. Assignments are often self-initiated.
• Work on highly complex technical problems and provide solutions that are highly innovative and ingenious to a broad range of problems.
• Trains and mentor others in specialized area.
• Effectively communicate and works cooperatively with others as part of a team.
• Ability to compile and organize technical data using Excel, Word, or Access.
• This is not an exhaustive list of duties or functions

Note:

• Must be within commuting distance, or willing to relocate, near Louisville, Colorado