The Opportunity:

We are currently searching for a Senior Mechanical Engineer to join our team. This position will be responsible for designing, fabricating, and testing mechanical components for state-of-the-art medical devices in an environment where safety, efficacy, and innovation are compulsory. The ideal candidate is a self-starter with experience developing electro-mechanical devices, and a passion for being part of a team developing medical technologies that improve people’s lives.

Key Responsibilities:

· Quickly understand novel technologies and engage with moving them forward towards a product

· Apply critical thinking and analytical skills to determine mechanical specifications for the medical device

· Design, develop, and implement highly-robust mechanical parts and assemblies, starting with building a proof-of-concept prototype followed by the design and implementation of a final production quality medical device

· Participate in technical design and design review meetings to discuss challenges related to the medical device

· Work closely with electrical and firmware engineers to solve cross-functional design challenges

· Create and maintain documentation packages suitable for manufacturing transfer and regulatory submission

· Interface with Business Development to transfer new activities into the company

· Manage a limited number of concurrent projects primarily of a mechanical scope in a team consisting of 2 - 3 engineers from multiple disciplines

· Prepare project reports and other program or technical documentation

· Provide senior technical leadership and mentoring to the Mechanical Team members

Technical Qualifications:

· Bachelor’s Degree in Mechanical Engineering

· 5+ years of industry experience in design, development and testing of mechanical systems

· Ability to generate mechanical architecture and componentry concepts for complex mechanical systems

· Intermediate to advanced proficiency in CAD modelling SW

o Proficiency with advanced part modelling, surface modelling and parametric feature modelling is desired

· Ability to generate, dimension and tolerance engineering drawing packages for assemblies of moderate to high complexity

o Understands GD&T and tolerance stack-ups

· Experience with design for manufacturing, assembly, and cost; manufacturing methods and production processes

· Experience with static structural finite element analysis (FEA or FEM)

o Experience with CFD for simple fluidic systems is a plus

· Experience with heat transfer and fluid flow analysis

· Ability to lead biocompatibility analyses and design for compliance with ISO 10993-1

· Able to select appropriate sterilization processes and analyze material effects

· Ability to lead hazard analysis, product and hardware FMEA processes

· Ability to generate design input requirements for complex mechanical systems and components

· Ability to interpret and design for compliance with medical / mechanical safety standards

· Experience with 3D printing and model making for usability testing

· Experience working in a safety-related quality process is a plus

Additional Qualifications:

· Ability to interact well with clients

· Excellent critical thinking and analytical skills

· High level of initiative with ability to self-manage

· Strong written and verbal communication skills

· Strong presentational skills

· Strong communication and reporting skills

· Investigate clinical requirements

· Regulatory agency experience including UL, CE and FDA approval processes preferred

Sterling Medical Devices (SMD) is an Equal Opportunity Employer. SMD does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.”

Local candidates only at this time, please. We do not offer relocation assistance.  Job will be based in either New Moonachie, Jersey or Lenexa, Kansas

No third-party candidates please.

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