Component Engineer

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Component Engineer

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    Component Engineer
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We are looking for a Component Engineer to join our client in Danvers, Ma. 

As a member of the contract manufacturing team, drive pre-market operational  excellence in development projects involving contract manufacturing partners through effective partnership with external suppliers and internal cross functional teams to assure that our products meet/exceed quality/service/cost/compliance expectations upon launch. 



  • Support Engineering team on PDP projects, product transfers, CM conversions, cost saving and material replacement projects.
  • Determines specific requirements of manufacturing operation to specify equipment, fixturing and process parameters.
  • Continuous improvement and cost analysis.  Identify, evaluate and implement opportunities for improvement in manufacturing processes.
  • Lead DRM/improvement projects, both proactive and reactive
  • Provide engineering support to contract manufacturing operation. 
  • Lean and Six Sigma understanding; ability to time study, calculate Takt time, line level; Ppareto rejects, filter key inputs to process to generate a DOE. Design and execute optimization DOEs.
  • Utilize basic statistical methods to support engineering testing.
  • Compare internal yield/external complaint failure model with the process FMEA and accurately assess quality impact.
  • Lead engineering projects intended to replace obsolete materials, validate process changes, or implement machinery upgrades/replacement.
  • Tasks including: Project management deliverables; protocol generation; report generation; supplier interactions; technical assessment of changes; and risk review. 
  • Process change orders or supplier change orders in configuration management software (AGILE).
  • Create purchase orders in purchasing software.
  • Lead supplier audits and drive First Time Quality events to reduce risks
  • Use Design Reliability Manufacturability (DRM) methodology to improve product quality and reliability:
  • Understand production lines- asses risks, audit, how cell is aligned, lean maturity
  • Ability to work with cross-functional design teams. Be the voice of ops to explain implications of design changes on regulations and lines
  • Ability to understand design print creation and finalization, tolerances,
  • Establish reliability & predictive capability of process and components
  • Requirements flow down and tracing design outputs to inputs
  • Design of Experiments (DOE)
  • Deploy Lean and Six Sigma methodologies to ensure strong root cause investigations
  • Use Cell Operating System methodologies to drive operational excellence of work flows


  • BS degree in Engineering discipline (Biomedical, Manufacturing, Mechanical, Industrial, Operations Research, etc.)
  • 3 years of experience in regulated medical device or pharma industry


  • Team dynamic skills (communication, accountability, decision-making, feedback, meeting management, managing conflict).
  • Virtual interaction with teams
  • Computer literate
  • Statistical skills
  • Knowledge of statistical software.
  • Technical writing skills
  • Verbal, written and presentation skills
  • Project management skills
  • Working with suppliers supporting produce development on pre-market products (focus on components and subassemblies



  • Master of Engineering
  • MBA
  • PMP
  • 5 years of experience
  • Experience in an ISO13485/GMP environment preferred. 
  • Engineering experience with disposable medical devices also preferred.
  • Six Sigma, Constraint Management and Lean Manufacturing experience preferred
  • Supplier Auditing experience/certification
  • Strong Relationship building skills
  • Knowledge of materials and related processes








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