Engineering Support Technician

JOB TITLE: Engineering Support Technician (Permanent, Full Time)

DEPARTMENT &

LOCATION: Nova Eye Product Development (Fremont, CA, USA)

REPORTS TO: Engineering Manager (based in Adelaide Australia)

LIAISES CLOSELY WITH: Manager, Manufacturing Operations

ROLE PURPOSE:

We are looking for a full-time Engineering Support Technician with hands-on lab skills who possesses a process improvement mentality to join the team at our iTrack design and manufacturing facility in Fremont, CA. A description of the iTrack catheter is shown at the end of this position description. The technician will assist in bringing next-generation glaucoma surgical device products to market and supporting current production. The Engineering Support Technician position involves responsibilities in the design transfer process and supporting the continuation and iterative improvement of ongoing production processes. Design for manufacturability (DFM) input to colleagues within the product development team throughout the product development lifecycle will also form an integral part of the role.

Tasks will also include performing verification and validation activities, report writing, reviewing and updating mechanical engineering files, and providing manufacturing support. Duties may also include prototyping concepts, conducting proof-of-principle tests, and general support of company operations in cross-functional areas.

GOOD ENERGY:

As a small technology company pursuing rapid growth, culture is imperative to Nova Eye’s success. Therefore, the successful applicant must possess a strong ‘can-do’ attitude and bring good energy and a positive approach to problem-solving to the team.

The Engineering Support Technician is an important member of the distributed product development team, a team of hands-on, technical professionals responsible for product development from concept and specification to design transfer to production.

All product development team members are expected to use the team’s guiding principles to guide them through their work. These guiding principles are listed at the bottom of this job description.

RESPONSIBILITIES:

• Hands on technical support of manufacturing with engineering and technical solutions.
• In collaboration with engineering and manufacturing, develop, test, and implements tools, fixtures and equipment along with the preparation and development of MPI’s required for manufacturing processes.
• Assemble and troubleshoot prototypes, production components and testing fixtures.
• Critical review of existing products using CAD models, assemblies, and drawings from a DFM perspective.
• Work with the product development, regulatory and QA teams as required, in product development and support activities.
• Assist Quality department with establishment of IQA processes and IQA tasks when needed.
• Assist with training of production and quality staff as required.
• Support Document Control in maintaining DHFs.
• Manage product design data in support of the QA team to ensure that the technical data complies with internal and external requirements.
• Assist with product specifications, translating product briefs into system specifications.
• Plan and manage project activities.
• Plan, coordinate, and run product lifecycle reviews in accordance with ISO13485 and GMP.
• Plan and conduct V&V and clinical activities through the management of domain experts as part of the product development process.
• Assist as required in manufacturing engineering and quality engineering activities.
• Reporting on project activites on a regular basis.
• Comply with company policies and procedures.
• Perform other duties as required.
• Travel as required.

QUALIFICATIONS / EXPERIENCE

• 5+ years of experience in a project, technician, engineering or quality role within a medical device company.
• Experience interacting with suppliers and technology partners.
• Experience working with quality systems, such as ISO requirements, GMP guidelines, FDA regulations and medical device design control.
• Experience interacting with operational management, quality and technical staff in a manufacturing environment.
• Experience with electronics, basic troubleshooting an advantage.
• Knowledge of materials, single-use medical devices, and the injection moulding process will be an advantage.
• Knowledge of CAD, Solidworks or Autodesk Inventor to manage documentation.
• Diploma in Biomedical, Engineering OR equivalent combination of education and experience.
• Able to work well in a team as well as individually.
• Excellent written and verbal communication and problem-solving skills.
• Proficiency in MS Office applications.
• Ability to follow company procedures and medical device regulatory requirements.

PRODUCT DEVELOPMENT TEAM GUIDING PRINCIPLES

• We take the utmost pride in our work
• We raise the tide: A rising tide lifts all ships. Product development is a ‘team sport’, and each team member contributes to company culture and capability.
• We leave our egos at home: We ask one another questions and openly recognize what we do not know, seeing it as an opportunity for growth and personal improvement, not as a weakness.
• We are balanced and pragmatic: We are pragmatic problem solvers. We apply judgment and experience to balance trade-offs between competing interests. We simplify processes and technologies while advocating a long-term view.
• We build knowledge as a team: By diligently recording our work, and its workings, for posterity, knowledge management and distribution among the team, present and future.
• We respect and cooperate with other departments: We recognize that we provide a service to other departments such as Quality and Operations/Production and respect their skills, their processes and cooperate/communicate effectively in every way to the benefit of the business and the other department staff.
• We respect what came before: We respect our predecessors and the decisions they have made. We will assess systems and designs within the current context and make the best decision available moving forward.
• We learn from our mistake: We will make mistakes. We must make mistakes. Without mistakes, there can be no innovation and no growth. However, a good product development function records their mistakes and learnings and makes that record digestible by others within the team.
• We work to identify and negate our biases: We acknowledge that we all have biases, and we work to identify and then negate those biases to reach the best outcomes as a team.
• We are flexible: We are adaptable to the changing priorities synonymous with fast-paced R&D and innovation. As a team distributed around the world, we will, on occasion, need to join meetings or video calls outside of the traditional ‘9 to 5’ workday.
• We are hungry for personal growth: We must always be looking to learn and expand our capabilities and the capabilities of those around us.
• We work to maintain a positive mindset: We work hard with the team to solve and overcome the challenges that arise in a product development environment.
• We are empathetic: We consider the impact of decisions and actions on other functions within the business, on our customers and their patients. This includes respect for project timelines, as other business functions rely on our team to deliver on time.

COMPANY BACKGROUND:

Nova Eye Medical is a growth stage medical technology company developing, manufacturing, and marketing products to treat the developed world’s two leading causes of blindness: age-related macular degeneration (AMD) and glaucoma.

Nova Eye has a distributed engineering and product development team with team members in California, Australia and New Zealand. This role focuses on the company’s glaucoma business, which entails developing and producing consumable glaucoma devices and implants and supporting systems.

ITRACK CATHETER:

• Our proprietary iTrack(TM) technology is a key player in the MIGS market.
• The iTrack(TM) is a unique, patent-protected microcatheter for treating patients with glaucoma.
• It is used to clear and flush the main ocular drainage systems that are compromised as a result of glaucoma.
• Investment in product development being undertaken to improve surgical efficiency and physician take up.

**Please submit resume with a cover letter

Job Type: Full-time

Salary: $35.00 - $55.00 per hour

Expected hours: 40 per week

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• Monday to Friday

Application Question(s):

• Do you have a Diploma in Biomedical, Engineering OR equivalent combination of education and experience?
• Have you worked in the medical device field before?

Education:

• Associate (Preferred)

Experience:

• medical device project, technician, engineering or quality: 5 years (Required)
• quality systems: 1 year (Preferred)

Ability to Relocate:

• Fremont, CA: Relocate before starting work (Required)

Work Location: In person