Manufacturing Engineer II

Recor Medical-posted 2 months ago
$94,484 - $106,350/Yr
Mid Level
Palo Alto, CA
11-50 employees
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The Manufacturing Engineer II is responsible for providing engineering support to existing products as well as process development for new products. At Recor Medical, we are pioneering Ultrasound Renal Denervation (uRDN) therapy to treat hypertension, the leading cardiovascular risk factor in the world. With our Paradise™ uRDN System, we’re on a mission to provide the millions of people who suffer from hypertension with a non-drug and minimally invasive option to lower their blood pressure.

  • Collaborate with Production to provide sustaining support in resolving product/process problems in a clean environment room.
  • Responsible for tasks involving designing, developing, testing and implementing processes, tooling, and fixtures for commercial product.
  • Participate as an extended team member for new product introduction, including scaling up, stabilizing and transfer to alternate sites.
  • Contribute to the development and maintenance of process FMEAs, Manufacturing Process Instructions (MPIs), and other documentation.
  • Support efforts to resolve quality related events (NCMR, CAPA, Audit Finding) using hands-on investigation and root cause analysis.
  • Create and release label files used for printing product labels.
  • Generate and execute test plans, verification, and process validation protocols and reports.
  • Other duties as assigned.
  • Bachelor/Master of Science degree in Engineering with a minimum of 2 years of experience in medical device industry.
  • Understanding medical device processes and assembly knowledge to drive product yield and performance.
  • Knowledge of and compliance with applicable Quality System requirements such as QSRs, FDA, ISO, MDD, MDR and other applicable regulations.
  • Familiar with Medical Device Design Controls.
  • Experience with Process Validation of Medical Devices (IQ-OQ-PQ).
  • Basic understanding of Statistics (Cpk, Hypothesis Testing, DOEs, GR&R) and familiar with statistical software (JMP, MiniTab) a plus.
  • Ability to create and maintain drawings using CAD (SolidWorks).
  • Excellent oral and written communication skills.
  • Self-motivated, action oriented and result oriented.
  • Salary: $94,484 - $106,350 (Annual Base Salary)
  • The successful candidate's starting base pay will be determined based on job-related skills, experience, qualifications, work location and market conditions.
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