Manufacturing Engineer II

Manufacturing Engineer II page is loaded## Manufacturing Engineer IIremote type:
Onsite locations:
Palo Altotime type:
Full time posted on:
Posted 4 Days Agojob requisition :
R10243

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. Join us on our journey and make a meaningful impact on the lives of people around the globe.
** Position Summary
** The Manufacturing Engineer II is responsible for providing engineering support to existing products as well as process development for new products.
** Responsibilities and Duties
*** 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.
** Requirements
* ** 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, Mini Tab) a plus.
* Ability to create and maintain drawings using CAD (Solid Works).
* 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. The expected base pay range for this role may be modified based on market conditions.
** Equal Employment Opportunity
** At Recor Medical, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.

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