Sr R&D Engineer, Systems - Shockwave Medical

Johnson & Johnson; Santa Clara (CA); On-site; USD 103,000 - 166,000; Full time

Job summary

An established industry player is seeking a Sr. R&D Engineer to join their innovative team focused on developing cutting-edge medical devices. This role involves engaging in cross-functional teams to design and document products, ensuring compliance with industry standards such as FDA and ISO. The successful candidate will leverage their expertise in biomedical, mechanical, or electrical engineering to drive product development from concept to commercialization. With a commitment to quality and safety, this position offers a unique opportunity to contribute to life-changing technologies while enjoying a competitive compensation package and comprehensive benefits. If you're ready to make a significant impact in the medical field, this role is for you.

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Short-term Disability

Long-term Disability

401(k) Retirement Plan

Vacation Time

Sick Leave

Holiday Pay

Qualifications

• 5+ years of medical device experience or 3+ years with a Master's degree.
• Familiarity with risk management processes including FMEA and FTA.

Responsibilities

• Design and develop products in compliance with FDA and ISO standards.
• Support quality audits and maintain documentation in lab notebooks.

Skills

Biomedical Engineering

Mechanical Engineering

Electrical Engineering

Risk Management

Communication Skills

Education

Bachelor's degree in Biomedical Engineering

Master's degree in Biomedical Engineering

Tools

JAMA

Design History Files (DHF)

Design Master Records (DMR)

Traceability Matrices

ISO 13485

Job description

Job Description - Sr. R&D Engineer, Systems - Shockwave Medical (2506233450W)

Position Overview

The Sr. R&D Engineer, Systems will work with cross-functional teams to develop and sustain products at Shockwave Medical that satisfy customer needs and drive business strategies. The Sr. R&D Engineer, Systems will engage in specification writing and development; test and report writing and development; execute testing; DHF maintenance; and provide support to other departments as required.

Essential Job Functions

1. Design and develop product(s) and documentation in full compliance with the company’s Design Control requirements and consistent with FDA, ISO, and MDD criteria.
2. Participate on cross-functional development teams that manage projects from concept through commercialization.
3. Evaluate existing document architecture and assess gaps and dependencies.
4. Work with stakeholders to establish project needs and functional group interfaces.
5. Work with on-market groups and data sets to assess device performance.
6. Support sustaining activities for on-market products.
7. Support quality audits and follow-up activities.
8. Ensure lab notebooks are documented in a timely manner and consistent with the applicable SOP.
9. Develop protocols/reports and perform product in-vitro, in-vivo verification and validation testing.
10. Good written and verbal communication skills to convey complex concepts and approaches. Provide support to operations and regulatory initiatives as required.
11. Other duties as needed.

Qualifications

1. Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or Electrical Engineering with 5+ years of medical device experience, or a Master’s degree in Biomedical Engineering, Mechanical Engineering, or Electrical Engineering with 3+ years of medical device experience.
2. Familiarity with Design History Files (DHF), Design Master Records (DMR), Traceability Matrices, and other outputs of the Product Development Process.
3. Familiarity with risk management processes and applications including FMEA, FTA and general risk analysis.
4. Working knowledge of cGDP, 820.30 and ISO 13485.
5. Ability to work in a fast-paced environment, managing multiple priorities. Experience with JAMA is a plus.
6. Employee may be required to lift objects up to 25lbs.

Additional Information:

The anticipated base pay range for this position is $103,000 to $165,600 annually. The Company maintains highly competitive, performance-based compensation programs.

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

Employees are eligible for the following time off benefits:

1. Vacation – up to 120 hours per calendar year.
2. Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year.
3. Holiday pay, including Floating Holidays – up to 13 days per calendar year.
4. Work, Personal and Family Time - up to 40 hours per calendar year.

NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as assigned or negotiated to meet the ongoing needs of the organization.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.