Staff Manufacturing Engineer - Capital Equipment
Staff Manufacturing Engineer - Capital Equipment
Posted on :
11-04-2025
Employer Active
1 Vacancy
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Yearly Salary
$ 159000 - 178000
Vacancy
1 Vacancy
Posted on :
11-04-2025
Job Description
Job Title: Staff Manufacturing Engineer Capital Equipment
Location: This position is based in our Campbell California offices. This position is onsite and fulltime
Why Telos Health
At Telos Health we are developing novel roboticassisted technologies and interventional capabilities that will forever change the disparate outcomes of ischemic stroke a disease that impacts close to a million people a year in the U.S. and 10 million worldwide. Not only is Telos changing the way stroke is treated but also bringing this treatment to the greater population who is currently without. We are actively building a team who is focused on developing novel solutions for this complex disease a disease in which one in four adults will face in their lifetime.
What Youll Do
This position is responsible for the following areas: InHouse and Contracted Manufacturing Manufacturing Engineering and Equipment Planning/Engineering in accordance the companys Quality System and customer requirements. This position will ensure that assigned projects product/s are designed to facilitate manufacturability and will be responsible for technology transfer to manufacturing and ultimately scalability for commercialization for Telos robotic system. This position may be an individual technical innovation contributor or as needed supervise a technical team with responsibility for mentorship and development of other MFG engineers.
What Youll Bring:
Employee Benefits include a stake in our collective success with stock options competitive salaries a 401k plan health benefits generous PTO and a parental leave program.
Join Us! Apply today.
Salary Range: $annually
Please note that the salary information is a general guideline only. Imperative Care considers factors such as scope and responsibilities of the position candidates work experience education/training key skills and internal equity as well as location market and business considerations when extending an offer.
Location: This position is based in our Campbell California offices. This position is onsite and fulltime
Why Telos Health
At Telos Health we are developing novel roboticassisted technologies and interventional capabilities that will forever change the disparate outcomes of ischemic stroke a disease that impacts close to a million people a year in the U.S. and 10 million worldwide. Not only is Telos changing the way stroke is treated but also bringing this treatment to the greater population who is currently without. We are actively building a team who is focused on developing novel solutions for this complex disease a disease in which one in four adults will face in their lifetime.
What Youll Do
This position is responsible for the following areas: InHouse and Contracted Manufacturing Manufacturing Engineering and Equipment Planning/Engineering in accordance the companys Quality System and customer requirements. This position will ensure that assigned projects product/s are designed to facilitate manufacturability and will be responsible for technology transfer to manufacturing and ultimately scalability for commercialization for Telos robotic system. This position may be an individual technical innovation contributor or as needed supervise a technical team with responsibility for mentorship and development of other MFG engineers.
- As a technical individual contributor oversee the builds for capital hardware and equipment.
- Manage inhouse and contract manufacturing activities and relationships to ensure products are manufactured in accordance with product plans and quality/regulatory requirements.
- Ensure Supply Chain is aware of inventory raw materials and component requirements per the planned build schedule; manage and be accountable for material issued to production or engineering projects.
- Conceptualize and implement manufacturing improvements tooling and systems to increase productivity and/or improve yields.
- Define manufacturing or process related technologies to reduce manual operations and/or improve repeatability.
- Participate in the selection of suppliers for manufacturing components.
- Work closely with Quality to create manufacturing and process related SOPs and Wis.
- Develop manufacturing processes and Manufacturing Process Instructions (MPIs) and lot history records (LHRs) or Device History record (DHRs) in collaboration with R&D and Quality.
- Perform time studies for each manufacturing process and identify process development initiatives.
- Ensure that all products are manufactured in compliance with the company Quality System customer needs budgetary requirements schedule requirements and the regulatory requirements.
- Work with Quality personnel to define inprocess inspections and testing and resolve quality and yield issues through continuous improvement projects.
- Provide oversight and coordinate crossfunctional 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.
- Participate in manufacturing team meetings to ensure adequate communication between members and develop positive proactive working relationships with other staff.
- Develop manufacturing specifications for products; coordinate all process validation activities with Quality IQ/OQ/PQ.
- Determine tooling equipment and fixture needs for the timely and costeffective manufacture of products.
- Define requirements to ensure smooth transition of products into manufacturing while assuring manufacturability achieving cost targets and conformance with regulatory and quality requirements.
- Work with suppliers to ensure parts/services are properly documented and meet specifications.
- Manage specifications for sub and final assemblies; identify tooling requirements design/document/procure/verify tooling.
- Establish manufacturing line and approve DCOs for manufacturing engineering.
- Define critical process outputs and ensure that MPIs and training methods confirm the outputs.
- Using continuous improvement techniques work with Quality Assurance to identify and implement programs to drive down cost and improve yield and reliability.
- Plan equipment and workflow layouts in manufacturing areas. Manage manufacturing equipment design and development to ensure that equipment is costeffective and meets manufacturing specifications and maintain and coordinate all calibration and preventive maintenance activities in conformance with the Companys Quality System requirements.
What Youll Bring:
- BS in Engineering or related discipline and 8 years of related experience; or MS in Engineering with 8 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 the MDD and knowledge of relevant standards.
- Ability to detail project plans effectively.
- Familiar with GMP GDP procedures and requirements.
- Familiar with Design Control procedures and requirements.
- Excellent communications skills (both written and verbal) required.
- Ability to work independently or in team setting required.
- Project management experience preferred.
- Working knowledge of quality system requirements and compliance (e.g. traceability QSRs ISO MDD/MDR requirements) and other applicable regulations.
- Experience working with ERP/MRP/Documentation control systems
- Understanding of contracts (supply services nondisclosures agreements etc.. Skilled in the use of Microsoft office suite especially Word PowerPoint Excel
- Previous exp. in medical device company preferred
Employee Benefits include a stake in our collective success with stock options competitive salaries a 401k plan health benefits generous PTO and a parental leave program.
Join Us! Apply today.
Salary Range: $annually
Please note that the salary information is a general guideline only. Imperative Care considers factors such as scope and responsibilities of the position candidates work experience education/training key skills and internal equity as well as location market and business considerations when extending an offer.
Required Experience:
Senior IC
Employment Type
Full-Time
Department / Functional Area
Key Skills
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