Principal Packaging Engineer
Campbell, CA
Full Time
Engineering
Experienced
Title: Principal Packaging Engineer
This position is based in our Campbell, California offices. This position is on-site & full-time
Why Telos Health?
At Telos Health, an Imperative Care company, we are developing novel robotic-assisted 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 You’ll Do:
This position will be assigned to lead packaging design and development, from early phase through Production, of novel sterile and non-sterile packaging for neuro-interventional medical devices such as catheters, guidewires, etc., as well as drapes and other sterile and non-sterile components/devices to be used with the Telos Health robotic platform. They will participate in creative brainstorming, conceptualization, and hands-on prototyping of design concepts independently and cross-functionally with other engineers. Responsibilities will include creative problem solving, design and development, engagement with and management of outside suppliers and test facilities, test method development, design documentation, specification setting, prototyping, testing, data analysis, and test report generation.
What You’ll 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: $180,000 to 195,000 annually
Please note that the salary information is a general guideline only. Imperative Care considers factors such as scope and responsibilities of the position, candidate's work experience, education/training, key skills, and internal equity, as well as location, market and business considerations when extending an offer. As part of our total rewards package, Imperative Care offers comprehensive benefits including a 401k plan, health benefits, generous PTO, a parental leave program and emotional health resources.
This position is based in our Campbell, California offices. This position is on-site & full-time
Why Telos Health?
At Telos Health, an Imperative Care company, we are developing novel robotic-assisted 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 You’ll Do:
This position will be assigned to lead packaging design and development, from early phase through Production, of novel sterile and non-sterile packaging for neuro-interventional medical devices such as catheters, guidewires, etc., as well as drapes and other sterile and non-sterile components/devices to be used with the Telos Health robotic platform. They will participate in creative brainstorming, conceptualization, and hands-on prototyping of design concepts independently and cross-functionally with other engineers. Responsibilities will include creative problem solving, design and development, engagement with and management of outside suppliers and test facilities, test method development, design documentation, specification setting, prototyping, testing, data analysis, and test report generation.
- Technical lead in the creation of detailed specifications, prototypes, and testing of new device packaging and sterile barrier designs based on customer (user) and design requirements
- Research, evaluate, and recommend materials and suppliers/contract manufacturers for design and development and longer-term Production designs and sterile barrier sealing methods
- Ensure that assigned projects are designed to facilitate manufacturability and cost constraints, and lead technology transfer to manufacturing (to include development of manufacturing tools and/or aids)
- Lead, conduct, and/or participate in workflow studies to assess procedural set up, intra-op procedures, and tear-down/disposal as related to device packaging and related devices
- Lead brainstorming sessions to generate new intellectual property and work with senior staff and/or attorneys to write and research patent claims
- Execute studies and experiments, product testing, and protocols in accordance with project plans, and collect and compile test data, and create test reports
- Work within multi-disciplinary project team to identify requirements, and evaluate and decide upon design solutions, and specifically work closely with the hardware, disposables, clinical, and UI/UX groups to understand requirements for clinical workflow and usability
- Create CAD (SolidWorks) drawings conforming to requisite ANSI and Company standards to document device designs and related fixtures and tooling
- Create documentation including design drawings, test reports, engineering reports, and other technical documents in accordance with Quality System requirements
- Research and specify appropriate equipment and tooling needed for ongoing prototyping, testing, and longer-term Production packaging and manufacturing
- Oversee the activities of technicians, more junior level engineers, and/or outside test facilities in completing packaging testing/inspection and prototype construction, as applicable
- Work collaboratively with Operations to qualify equipment and develop robust procedures to support successful packaging validation testing
- Work collaboratively with Quality to support successful biocompatibility testing and sterilization validation
What You’ll Bring:
- Bachelor’s or master’s degree in Engineering (Packaging, Mechanical, or related discipline) with 12+ years of related experience with BS degree or 10+ years with MS or Advanced degree; or equivalent combination of education and work experiencein the medical device or related regulated industry
- 5+ years previous experience in technical innovation role, with specific focus on the design, development, manufacturing, and/or testing of unique/novel medical device packaging, and related manufacturing equipment and techniques, such as thermoforming, injection molding, heat sealing
- Preferred experience in a start-up environment
- Extensive knowledge of materials associated with medical device packaging and related sterilization methods (specifically ETO) and validation requirements
- Experience and familiarity with statistical methods such as such as SPC, SQC, and DOE and use and implementation of Statistical Analysis Software (Minitab or similar)
- Proficiency using SolidWorks, for designing and documenting devices, tooling, and fixtures
- Familiarity with and ability to safely and efficiently operate machine shop equipment (mill, lathe, drill press, etc.) and 3D printing equipment preferred
- Ability to complete projects individually and to lead projects as part of a cross functional team
- Extensive experience in full R&D product life cycle (concept through regulatory approval/market release)
- Extensive experience with Design Control procedures and requirements and working under regulated quality systems such as GMPs, ISO 13485, and MDR
- Demonstrated excellent written and verbal communications skills as a member of a cross functional team
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: $180,000 to 195,000 annually
Please note that the salary information is a general guideline only. Imperative Care considers factors such as scope and responsibilities of the position, candidate's work experience, education/training, key skills, and internal equity, as well as location, market and business considerations when extending an offer. As part of our total rewards package, Imperative Care offers comprehensive benefits including a 401k plan, health benefits, generous PTO, a parental leave program and emotional health resources.
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