Senior Principal Engineer

jj; Irvine (CA); On-site; USD 122,000 - 213,000; Full time

Benefits offered by this job

401(k)

Pension

Vacation

Sick time

Holiday pay

Parental leave

Bereavement leave

Volunteer leave

Job summary

Johnson & Johnson in Irvine, CA seeks a Senior Principal Engineer, R&D to direct development of new medical devices and manufacturing methods. You will lead internal and external teams, translate clinical needs into innovative solutions, and drive quality through regulated processes.

You will oversee complex projects, mentor engineers, and ensure compliance with health, safety and regulatory requirements while interfacing with physicians to address unmet clinical needs.

Qualifications

• Knowledge of medical device development and manufacturing.
• Experience leading cross-functional teams on complex projects.
• Strong communication and leadership capabilities.

Responsibilities

• Directs large engineering projects with cross-functional teams.
• Leads development of new techniques and processes for medical devices.
• Mentors junior engineers and reviews design work and validations.
• Interacts with physicians to identify clinical needs and translate into solutions.
• Ensures compliance with FDA QSR and ISO13485 standards.

Skills

Contract management

Design thinking

Fact-based decision making

Feasibility studies

Financial competence

Leadership

Lean supply chain

Mechanical engineering

Product development

Project management

PMM

STEM

Vendor management

Education

Bachelor's degree in Mechanical Engineering

Masters degree or equivalent preferred

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Supply Chain Engineering

Job Sub Function:

Mechanical Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Irvine, California, United States of America

Job Description:

Local Job Title: Senior Principal Engineer, R&D

Scope: Biosense Webster Inc.

Pay Grade: 31

Exemption Status: Exempt

Job Function: R&D

Job Sub-function: R&D Engineering

SECTION 1: JOB SUMMARY*

Engineer 6

R&D

Responsible for directing the technological development of new medical devices and their methods of manufacture. This includes selecting, evaluating, and developing product and manufacturing technologies that are appropriate for the market. It also requires interfacing with physicians to identify new technologies that will address clinical needs. They will lead both internal engineering teams and external contract engineering teams, as applicable.

Leads in the development of new and innovative technologies, treatments, solutions, and products. Participates on a high caliber multi-functional team to drive innovative approaches to product development. Performs high level research and development functions supporting the development of new products and processes.

SECTION 2: DUTIES & RESPONSIBILITIES*

Under general supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

Engineer 6 R&D

Applies intensive and diversified knowledge of engineering principles and practices in broad areas of assignments and related fields.

Makes decisions independently on engineering problems and methods and represents the organization in conferences to resolve important questions and to plan and coordinate work.

Requires the use of advanced techniques and the modification and extension of theories, precepts and practices of his/her field and related sciences and disciplines.

Requires experience in applying DfX methodologies in the design of medical devices.

Supervision and guidance related largely to overall requirements, critical issues, new concepts, and policy matters.

Consults with supervisor concerning unusual problems and developments.

Responsible for one or more of the following:

In a supervisory capacity, plans, develops, coordinates, and directs a large important engineering project or a number of small projects with many complex features.

As an individual researcher, carries out complex or novel assignments requiring the development of new or improved techniques or procedures.

Work is expected to result in the development of new or improved techniques or procedures.

Work is expected to result in the development of new or refined equipment, materials, processes, products, and/or methods.

Develops and evaluates plans and criteria for a variety of projects and activities to be carried out by others.

Assesses the feasibility and soundness of proposed engineering evaluation tests, products or equipment when necessary data are insufficient or confirmation by testing is advisable.

Performs as a consultant on a technical specialty, a type of facility or equipment, or a program function.

May technically supervise, coordinate and review the work of a small staff of engineers and technicians, estimates resource needs and schedules and assigns work to meet completion date, or, as individual researcher or staff specialist may be assisted on projects by other engineers or technicians.

Responsible for performing design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes.

Engineer 6 R&D:

• This job description applies to new product development and lifecycle management.

• Directing the work of R&D technicians/ interns performing research and development activities as applicable.

• Interfaces with various cross-functional team members to ensure that designs meet quality objectives and long-term requirements.

• Responsible for communicating business related issues or opportunities to next management level.

• Responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.

• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.

• Performs other duties assigned as needed.

SECTION 3: EXPERIENCE AND EDUCATION*

Engineer 6 R&D

Knowledge and skills to satisfactorily develop the responsibilities of the position. 10 to 12 years of experience, preferably related to the position.

University/Bachelors Degree in Mechanical Engineering, Biomedical Engineering or similar field.

Masters Degree or Equivalent is preferred.

Strong knowledge of the medical device industry and manufacturing technologies.

Familiarity with quality and regulatory systems including FDA’s Quality System Regulation, ISO13485, etc.

Must have an extensive experience in leading projects, developing processes and in documentation writing.

Experience with tools and equipment for product design and manufacturing.

Demonstrated experience developing technological solutions for medical device products.

SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS

Engineer 6 R&D

Ability to handle multiple priorities/projects in an effective manner and ability to provide technical leadership on cross-functional teams.

Excellent concept evaluation skills.

Ability to apply experience and lab skills to quickly arrive at appropriate technical solutions.

Must have excellent communication and interpersonal skills, the ability to express complicated technological ideas in layman terms, strong interpersonal skills and excellent organizational skills.

Strong analytical reasoning and problem-solving capabilities.

Ability to mentor and guide junior associates.

Self-driven individual who is capable and excited to learn about new technologies.

SECTION 5: TRAINING PLAN REVIEWED AND/OR UPDATED* (Check all that apply)

Note: If this is a new or updated JD, Training shall be notified per selections below.

Update to an Existing Job Description

Training plan/curriculum reviewed with Training Representative and updated.

Training plan/curriculum reviewed, and no update is required.

New Job Description

Training plan/curriculum implemented together with the Training Representative

Training plan/curriculum reviewed, and no update is required.

SECTION 6: ADDITIONAL POSITION REQUIREMENTS

This Section is Not Applicable

• Some work may be performed in a clean room environment.

• Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Safety Requirements: Adhere to company safety rules and practices. Be proactive in ensuring safety in work area. Immediately report incidents or unsafe conditions. Know emergency procedures.

• Company management reserves the right to add, delete or otherwise alter assigned duties at any time.

SECTION 7: RESPONSIBILITY FOR OTHERS & INTERNAL INTERACTIONS

This Section is Not Applicable

• The Senior Principal R&D Engineer reports to an R&D Lead/ Manager or Director.

• The Engineer may manage R&D technicians, interns and entry level engineers.

• Frequent interaction with various cross-functional team members as part of the product development function

SECTION 8: LOCATION & TRAVEL REQUIREMENTS

This Section is Not Applicable

• Location: Irvine, CA

• Travel: This position might be required to travel up to 30% (domestic and international). Frequent travel upon exception.

SECTION 9: EXTERNAL INTERACTIONS

This Section is Not Applicable

• Externally, the R&D Engineer is expected to assist with the interaction with suppliers and with customers for product development/feedback activities.

Required Skills:

Preferred Skills:

Contract Management, Design Thinking, Fact-Based Decision Making, Feasibility Studies, Financial Competence, Leadership, Lean Supply Chain Management, Mechanical Engineering, Product Development, Project Integration Management, Project Management Methodology (PMM), Science, Technology, Engineering, and Math (STEM) Application, Strategic Supply Chain Management, Tactical Planning, Technical Credibility, Vendor Management

The anticipated base pay range for this position is : $122,000.00 - $212,750.00

Please provide the benefits applicable. Required for US Positions. Please copy and paste the applicable benefits into the empty text box below, based on the type of role.

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

This position is eligible to participate in the Company’s long-term incentive program.

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

Vacation –120 hours per calendar year

Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year

Holiday pay, including Floating Holidays –13 days per calendar year

Work, Personal and Family Time - up to 40 hours per calendar year

Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child

Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year

Caregiver Leave – 80 hours in a 52-week rolling period10 days

Volunteer Leave – 32 hours per calendar year

Military Spouse Time-Off – 80 hours per calendar year

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits