R&D Technician

Route 92 Medical; San Mateo (CA); On-site; USD 48,000 - 59,000; Full time

Benefits offered by this job

Healthcare benefits from day one

Paid time off

Parental leave (12 weeks)

Cell phone stipend

Equity opportunity

Job summary

Route 92 Medical is seeking a hands-on technician to support engineering by building prototypes, performing validation builds, and transferring products to production in our San Mateo, CA office. The role involves extensive time in a clean room and collaboration with QA and manufacturing teams.

The ideal candidate has 3+ years in the medical device industry, familiarity with catheter manufacturing, and the ability to read engineering drawings.

Qualifications

• High School diploma or equivalent required.
• Experience with product testing using Instron is a plus.
• Ability to understand engineering assembly drawings preferred.

Responsibilities

• Function in a clean room environment for approximately 75% of the time.
• Collaborate with technicians to create prototypes and processes for new products or revisions with a zero-defect mindset.
• Assist in manufacturing of devices for verification, validation, and human use builds per GMP.
• Establish manufacturing processes for new products and train operators (in-house and at contract manufacturers).
• Learn and perform product testing and maintain test datasheets.
• Adapt to shifting tasks in a fast-paced product development program.
• Troubleshoot basic manufacturing issues with minimal oversight.
• Update supervisor on progress and improvement recommendations.
• Maintain thorough records of materials, parts, drawings and processes.
• Provide feedback on revisions to project engineers and other personnel.
• Train assemblers during transfer of products.
• Maintain clean, safe and organized work area.
• Coordinate with QA and Manufacturing on assignments and feedback.
• Support company policies, QSR and FDA regulations.

Skills

Instron testing

Engineering drawings

Education

AA in a technical field

High School diploma or equivalent

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

FullTime Technical San Mateo, CA, US

3 days ago Requisition ID: 1309

Salary Range: $35.00 To $43.00 Hourly

About Route 92 Medical

Route 92 Medical is on a mission to improve outcomes for patients undergoing neurovascular intervention. At the core is a reconsidered procedural approach, cutting-edge engineering, and innovative product design. Our portfolio targets the most significant challenges in neurointerventional care to deliver meaningful solutions. The company was founded by physicians developing thoughtful product solutions in collaboration with the world’s leading clinicians, who focus on improving procedural and patient outcomes.

Route 92 Medical is looking for dynamic, innovative people who are inspired by our mission to improve outcomes for patients undergoing neurovascular intervention.

We welcome team members who approach their work with courage, flexibility, persistence, and a willingness to assist others. Teamwork matters here. We are committed to collaboration and finding innovative solutions that advance neurovascular intervention, establishing Route 92 Medical as one of the premier companies in the field.

PURPOSE OF JOB:

This position will be onsite in our San Mateo, CA office support engineering by developing medical device prototypes, performing engineering validation builds, and transferring products to production.

RESPONSIBILITIES:

• This role will primarily function in a clean room environment for an estimated 75% of the time.
• Work with fellow technicians to create working prototypes, and processes for new product or product revisions which are consistent with a zero-defect level target.
• Contribute to manufacturing of devices for verification & validation builds, and human use builds per standard good manufacturing practices.
• Establish manufacturing processes for new products, support training new operators (in house and at contract manufacturer as applicable)
• Ability to learn and perform product testing as required for product development and maintain thorough and accurate test datasheets.
• Flexibly move between assignments and take on new tasks to meet the needs of a fast-paced product development program
• Ability to troubleshoot basic manufacturing issues with little to no oversight
• Update supervisor of work status or problems with recommendations for improvement or correction.
• Maintain accurate records of assignments and results including documentation concerning materials, parts used, concepts, designs, drawings and processes.
• Provide feedback on product revisions or new products to project engineers and other company personnel as appropriate.
• Train assemblers when transferring products.
• Maintain a clean safe and well-organized work area.
• Maintain close cooperation with Quality Assurance and Manufacturing in determining and completing assignments and providing feedback.
• Support company goals and objectives, policies and procedures QSR and FDA regulations.

SKILLS FOR SUCCESS:

• AA in a technical field preferred
• Experience with product testing utilizing Instron is a plus
• Ability to understand engineering assembly drawings is preferred

REQUIRED EDUCATION:

• High School graduate equivalent required

REQUIRED EXPERIENCE:

• 3+ years of experience in the Medical Device industry is required
• Must have experience with standard catheter manufacturing processes (hot boxes, UV bonding equipment, laminators) in a certified clean room environment
• Familiarity with Microsoft Word is required
• Must be comfortable working in a clean room environment for an estimated 75% of the time

BENEFITS & PERKS

• Comprehensive healthcare benefits are effective day one! R92M offers generous benefit options, including Medical, Dental, Vision, Life Insurance, FSA, HSA, Short-term and Long-term disability, Critical Illness Insurance, and Accident Insurance.
• Generous paid time off and 16 paid holidays, including a company-wide summer recharge week in July
• 12 weeks of paid parental leave for employees after 90 days of employment
• Monthly cell phone stipend

The actual base pay is dependent on several factors, including, but not limited to, work experience, market data, skills, geographic location, and business needs. The base pay range is subject to change and may be modified in the future. This role may also be eligible for equity.