Mechanical Engineer

Marlborough, Massachusetts


MARS Solutions Group is looking for an experienced Mechanical Engineer Marlborough MA USA. Our client is a leading global Healthcare technologies and digital solutions company with an enduring and innovative presence in the industry. They foster a challenging and empowering environment that cultivates personal and professional growth.

Essential Responsibilities

  • Technical point of contact for internal and external suppliers of plastic parts. Lead and manage Part Validations, working with SQE and Manufacturing, to deliver high quality components following IQ/OQ/PQ process. Contribute to Technical Design Reviews, Tooling Design Reviews, and Equipment Requirement Specifications. Collaborate closely and effectively with cross-functional departments worldwide including Marketing, Quality, Regulatory and Manufacturing to drive projects to completion.

Essential Responsibilities

  • Provide technical expertise and guidance in plastic part design, tool design, processing, and post processing operations
  • Experience with injection molding, extrusion, and thermoforming manufacturing and how part design, material selection, and tool design impact ability to produce high quality, repeatable parts
  • Work with Supplier Quality Engineers, Product Care, and Manufacturing to generate Part Quality Plans with suppliers
  • Execute on strategy to build tooling that is flexible, cost effective, and capable of consistently producing parts that meet Cytiva’s quality and regulatory requirements
  • Experience in New Product Development, Cost Reduction, and part quality improvement
  • Ability to lead mold design reviews and track mold build status
  • Ensure compliance with Design History File (DHF) and other QMS requirements
  • Identify, collaborate, and manage suppliers on material selection, tool design, manufacturing technologies, and specifications for components, subassemblies, and/or finished assemblies
  • Self-starter, creative problem solver and solution developer when presented with conflicting requirements, business demands and technical risks/issues
  • Maintain and develop competence required for the job
  • Strong written and verbal communication skills

 

Qualifications/Requirements

  • Bachelor’s degree in Mechanical, Plastics, or similar engineering or related field
  • 1-5 years relevant work experience in plastics processing, plastic part tooling, contract manufacturing, and/or OEM
  • Experience with plastics and relevant material characteristics, particularly as used in disposable medical devices, life science, or biomedical products
  • Working knowledge of plastic part and assembly manufacturing

Desired Characteristics

  • Proficient in CAD solid modeling tools; preferably SolidWorks and/or CREO
  • Familiar with CAE analysis tools; FEA, CFD and MoldFlow
  • Experience with plastic part bonding, heat staking, snap fits, welding, etc
  • Understanding of relevant regulatory and QA guidelines governing single-use plastic components such as Biocompatibility requirements per USP Class VI and USP 87 Cytotoxicity
  • Knowledge of bio-compatible material selection for sterile single-use application in bio-processing and/or medical device applications
  • Prepare engineering change requests, engineering change notices, bills of material, engineering specifications, and customer submittals
  • Experience with stage gate development process
  • Experience working in ISO 13485 environment
  • Design for Six Sigma or Green Belt/Black Belt Certification
  • Demonstrated analytic approach to problem solving
  • Experience in plastic part design and GD&T per ASME Y14.5 standards

About MARS Solutions Group:

MARS Solutions Group provides a range of opportunities for meaningful work by understanding that employment fit is a combination of people, process, and technology. We leverage our experienced and compassionate team to bring humanity to matching you with the right advanced technology role, and stay connected with you to help you attain your professional goals.