• Job Description

  Req#: 21-10456
  
  
  Job Description
  
  
  Job Title	Program Manager/ Principal Manufacturing Engineer Spine products manufacturing engineering experience preferred
  Relevant Experience (in Yrs)	12+ Years Medical Device Industry Manufacturing Engineering Experience
  Technical/Functional Skills	Technical/Functional Skills SME of medical devices industry functions Working knowledge of cGMP guidelines, FDA 21 CFR Part 820/210/211, ICH guidelines Intermediate/Advance CNC/Milling knowledge (must) Intermediate/Advance equipment and process validation (protocol generation and execution) (must) Experience in Star, $No Visa Sponsership$, Tornos, Mazak, Nakamura, Okuma, Mori Seiki, Mitsubishi, and/or Haas Intermediate/Advance statistic knowledge (T-test, ANOVA, Normality Test, Confidence/Tolerance Intervals, Capability Analysis, Control Charts) (must) Operation of machine and programming (nice to have) GD&T intermediate knowledge (must) MSA intermediate knowledge (must) Writing IQ, OQ, PQ protocol and report for manufacturing equipment Strong communication skills, both oral and written, to communicate effectively with customers and internal stakeholders Ability to work effectively in a cross functional team environment and build strong working relationships Responsibilities: Design transfer activities Gather required equipment, tooling, fixture information, speciation. Review older equipment for gaps and modification required if any. Verify the equipment to ensure its suitability/order for the intended purpose. coordinate to submit the purchase order - getting it order. Validation of CNC/Milling equipment, machining process Review & evaluate the mfg. process capability, Cpk, Ppk, robustness and characterization. Review the characterization to ensure its validity and find the window for recharacterization. Create a heat map to show the data gathered. Document the yield, throughput. Validate mfg, test and inspection procedures where appropriate: Long lead time & complex mfg. process gaps identification and remediation. Watch the current mfg. process/build, study the applicable mfg. procedure, identify the gaps, redline the applicable procedures, implement the changes in QMS per the CO process. Review equipment & mfg. process OQ, PQ, PPQ validation documents, process risk review Study the mfg. process/ build to document high operator dependent processes or how manual the process is. Create a color-coded representational map to plan the type & extent of training required Gather the DMR documents, review to ensure its completeness. Review Label & IFU changes, document the changes to be implemented
  Experience Required	12 Years Medical Device Industry Manufacturing Engineering Experience Spine products manufacturing engineering experience preferred
  Roles & Responsibilities	Lead mfg. Engineer
  Generic Managerial Skills
  Education	BS in Mechanical/Bio-medical Engineering 12 years exp MS in Mechanical/Bio-medical Engineering 10 years exp PMP certification preferred
  
  
  
  
  
  Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role. We promote and support a diverse workforce across all levels in the company.
  
  
  
  

• About the company

  We provide Consulting Services for our customer’s project and staffing needs. We also provide Data Management for Clinical Trials.

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