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Sr Mechanical Design Engineer

Moorpark, CA 93021

Posted: 02/26/2024 Employment Type: Contract Job Category: Engineering Job Number: 597089 Is job remote?: No Country: United States

Job Description


 

HM's Top Needs:
  1. 3 years of experience with Solidworks and PDM
  2.  Verification protocol writing, hands on test execution, and final test report writing
  3. Medical Device experience is highly preferred

 

Candidate will have experience in Medical Device product development.  I am looking for a versatile engineer that can execute mechanical design in Solidworks as well and work in PDM (Product Data Management) system.   The design work would be product design and fixture/test equipment.  The candidate will need to switch from design to test engineering as well.  An understanding of Medical Device quality systems is ideal, with experience in Design Verification and Validation.  I would like someone that can start with a list of requirements, draft a test protocol to verify each requirement, execute the testing, and write the final report.
 

Education Required:  BS in engineering, preferably Mechanical.

Years’ Experience Required:  3 years minimum, 5 years ideally
 
TECHNICAL SKILLS
Must Have
  • 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 Solidworks
  • 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

Responsibilities may include the following and other duties may be assigned. Researches plans designs verifies validates and develops mechanical and/or electromechanical products and systems such as metals instruments controls plastics robots engines machines and mechanical resonance hydraulic or heat transfer systems for production transmission measurement and use of energy. Recommends various technology options or approaches for system processes facility or program improvements in terms of safety performance efficiency or costs. May be responsible for the transfer from RampD to manufacturing.

SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies using specialized knowledge and skills normally acquired through advanced education typically University.

DIFFERENTIATING FACTORS

Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists may manage projects / processes.

Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives through building relationships and consensus to reach agreements on assignments.

Innovation and Complexity: Problems and issues faced are difficult and may require understanding of multiple issues job areas or specialties . Makes improvements of processes systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements.

Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts statuses ideas and issues to achieve objective and influence decisionmaking.

Leadership and Talent Management: May provide guidance coaching and training to other employees within job area. May manage projects requiring delegation of work and review of others' work product .

?Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience or advanced degree with a minimum of 2 years relevant experience.
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