Job DescriptionPerform medium sized and intermediate complex aspects of product/process development. Based on new product concepts and designs from engineers, support the development of products/processes for medical devices, including writing or verifying specifications and/or manufacturing procedures, designing fixtures and new products, and testing processes, equipment, and raw materials to ensure concepts and/or prototypes meet product/process development requirements. Job duties:
Technician Role:
- Perform set-up and testing of completed units or components under operational conditions to investigate designs or to obtain data for development, quality, or manufacturing.
- Record and analyze test results data using up to advanced statistical tools.
- Write test protocols, reports, and justification documents for regulatory submissions.
- Set up, adjust, repair, and operate laboratory equipment and instruments, which may include electrical wiring and other components.
Engineering Role:
- Provide technical direction to technicians and engineering specialists to meet project goals.
- Fabricate intermediate complex prototypes, manufacturing process, tools, and fixtures.
- Create drawings for prototypes, manufacturing processes, tools, and fixtures.
- Generate intellectual property, writing invention disclosures and support patent development, if applicable.
- Develop project plan with guidance from Project Managers.
- Support production or process development as required.
- Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.
- Perform other duties and projects as required.
Qualifications- Associate degree or technical certification in a related field by an accredited body or an equivalent combination of education and years of related experience.
- Minimum ten (10) years of progressive experience as a technician or in a similar capacity.
- Strong written and verbal communication skills.
- Ability to read, write, and speak in English.
- Well-organized and able to work in a fast-paced, self-directed environment.
- Strong computer skills in MS Word, Excel, Outlook, Teams, and related programs.
- Good laboratory or manufacturing practices and ability to follow required safety procedures.
Desired Qualifications- Bachelor's degree in applicable science-related field.
- Ability to read, redline and create Basic Drawings (BD), Manufacturing Processing (MP), Build Records (BR), and Quality Systems (QS).
- Ability to write and procure equipment to execute testing.
- Broad knowledge of the engineering or technical field, with the ability to read and prepare technical documentation. Knowledge of medical and technical development.
- Machine-building or equipment tooling skills.
- Strong knowledge of Good Laboratory Practices.
- Ability to provide mentorship and/or leadership support to project team members to guide, lead, and work through challenges and remove roadblocks to meet project objectives and timelines.
- Working knowledge of CAD software platforms such as SolidWorks.
- Experience in the medical device industry.
Physical- Extended periods of computer use.
- For certain tasks or areas, the ability to perform repetitive tasks under magnification or using a microscope for extended periods of time.
- Extended periods of standing or sitting.
- Light lifting, up to 25 lbs.
- Manual dexterity and hand-eye coordination to complete required tasks.
- Gowning may be required in controlled environments. Personal Protective Equipment use, including safety glasses and gloves, required for certain tasks or areas.
- May work with machinery and chemicals, requiring strict adherence to safety protocols.
- May be required within the position to be in an environment that can include radiation exposure (such as in Cathlabs).
Salary Range$96,210 - $126,275 (Financial compensation packages may be higher/lower than listed, & will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand)
