Sustaining Engineer II
About The Position
The Sustaining Engineer II will be a critical team member within the Product Development team at Jupiter with a focus on supporting ongoing design, process and quality improvements, supplier development, and supplier capacity expansions for Class II single use sterile catheter-based products. The Sustaining Engineer II will be supporting component non-conformances, root cause analysis, testing, qualification and supplier capacity ramp up for critical components, sub-assemblies and processes related to the pulmonary embolectomy aspiration system in support of full commercial launch. This individual will work cross-functionally with Quality, Manufacturing, and Operations within an FDA regulated medical device environment. This position reports directly to an Engineering Manager. The ideal candidate would act with passion and intensity in a medical device start-up that is fast-paced and collaborative and would display the ability to perform the requirements outlined below. For the right person, this position will be a tremendously exciting and career-defining opportunity, making core contributions to a new paradigm of catheter-based interventions. This is an in-office role.
Requirements
- Bachelor’s degree in engineering or related field
- 3 years in a related role
- Medical Device experience preferred
- Experience with root cause analysis
- Experience with process validation (IQ, OQ, PQ) preferred.
- Experience with supplier quality a plus.
- Strong communication and presentation skills.
- A strong desire to lead continuous improvement initiatives.
- Ability to work independently in a fast-paced environment while managing changing priorities.
- A demonstrated desire to work in a small medical device startup.
- A willingness to work hard, with a driven outlook and with a strong desire to succeed as an engineer, as a team, and as a company.
Nice To Haves
- Medical Device experience
- Experience with process validation (IQ, OQ, PQ)
- Experience with supplier quality
Responsibilities
- Continuous improvement of products, processes and suppliers.
- Lead and execute implementation of sustaining projects following change controls procedures.
- Manage internal and external communication for sustaining projects.
- Perform verification and validation testing as required to implement changes.
- Collaborate with Operations and Product Development to identify supply chain risks.
- Perform root cause analysis investigations of component failures and non-conformances.
- Collaborate with suppliers and internal teams to implement corrective actions.
- Support resolution of customer complaint investigations related to component issues.
- Perform statistical analysis of data and recommend supplier corrective actions based on process monitoring and statistical process controls.
- Collaborate with Quality and Product Development to define component inspection requirements.
- Collaborate with Product Development to recommend improvements to next generation products and processes based on RCA investigations.
- Support supplier development, qualification, and capacity scale up to meet forecasted demand.
- Collaborate with suppliers to create and execute validation plans.
- Recommend suppliers for next generation component development.
- Identify, develop and qualify new suppliers as required to mitigate supply chain risks.
- Create and maintain QMS documentation related to sustaining projects.
- Recommend improvements to SOPs and work processes.
- Work effectively within the confines of a regulated, quality system driven, FDA monitored medical device environment.
Benefits
- performance incentives
- equity opportunities
- comprehensive, top of the market medical, dental, and vision coverage
- top tier 401(k) with a best in-class plan design which includes strong employer contributions
- short and long-term disability
- life insurance
- commuter benefits
- wellness support
- healthy paid time off policy
- company holidays
- company-provided lunches
- Thursday socials
- monthly potlucks
- company events
- volunteer opportunities
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
