Senior Manufacturing Engineer
1 week ago
Location: Campbell, California
This is a full-time position with some travel required.
About Telos HealthWe are a company developing novel robotic-assisted technologies and interventional capabilities to treat ischemic stroke. Our mission is to change the way stroke is treated and bring this treatment to the greater population.
Job SummaryWe are seeking a Principal Manufacturing Engineer to join our team. As a key member of our manufacturing team, you will be responsible for ensuring that our products are designed and manufactured to meet quality and regulatory requirements.
Key Responsibilities- Establish and manage in-house and/or contract manufacturing activities and relationships.
- Develop manufacturing processes and Manufacturing Process Instructions (MPI's) and lot history records (LHR's) in collaboration with R&D and Quality.
- Lead the construction of prototypes for new products/processes or current product enhancements.
- Provide oversight and coordinate multi-functional operations project team activities from early project conceptualization through clinical testing.
- Create, maintain, and manage manufacturing tasks of project schedule, and ensure that critical timelines and/or budgets are established and met.
- Determine tooling and equipment needs for the timely and cost-effective manufacture of products.
- BS in Engineering or related discipline and 5+ years of related experience; or MS in Engineering with 3+ years of related experience; or equivalent combination of education and work experience in the medical device or related regulated industry.
- Knowledge of and experience in pilot/production line set up and validation in Controlled Environment.
- Experience working under quality systems designed to meet governmental regulations such as FDA QSR, ISO 13485, and the MDD.
- Familiar with GMP, GDP procedures and requirements.
- Must be able to travel.
- Excellent communications skills (both written and verbal) required.
- Ability to work independently or in team setting required.
- Project management experience preferred.
We offer a competitive salary, stock options, 401k plan, health benefits, generous PTO, and a parental leave program.
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