Sr Mechanical Design Engineer

Title: Sr Mechanical Design Engineer

Location: Moorpark California 93021

Type: W2 contract

Technical skills:

Must Have

10. Computer literacy in MS Word, Excel, PowerPoint

Experience generating technical documentation such as product requirements, specifications, engineering reports, test plans procedures, validation plans, and/or validation reports

Experience with Design Verification and Process Validation

Experience with solid modeling software such as Pro/Engineer or Solid works.

QMS

Nice to Have:

10+ Years design experience in medical device industry, Class III experience helpful, but not required

2-3 years’ experience with Sterilization Validation/ Microbiology is desirable

Cleaning Validation

Experience generating technical documentation such as product requirements, specifications, engineering reports, test plans procedures, validation plans, and/or validation reports

The candidate will work in a fast pace environment and is expected to have optimal critical thinking skills and a collaborative mindset to succeed in this role. The candidate is expected to have hands on EO validation sterilization experience and a working knowledge of ISO 11135:2014, ISO 10993-7:2008/AMD 1: 2019, and ISO 11737 series. Most importantly, the candidate must be a technical leader, able to handle a project with little to no oversight.

data acquisition analysis - Minitab

Job description:

3-5 years of experience, can be independent.

•         Some Mechanical Design with SolidWorks and PDM

•         Will wear other hats with manufacturing and quality partners

•         Test protocols, requirements modifications, be hands on to execute testing, write up reports

•         Understand med device documentation

•         Good communicator if they are having problems or challenges

HM's Top Needs:

1.            3 years of experience with Solid works and PDM

2.            Verification protocol writing, hands on test execution, and final test report writing

3.            Medical Device experience is highly preferred

Education Required:  BS in engineering, preferably Mechanical.

Years’ Experience Required:  3 years minimum, 5 years ideally.