We Hire America Jobs

Project Engineer, Enabling Tech R&D - 2406199615W

Description

Description:

Robotics & Digital Surgery, part of the Johnson & Johnson family of companies, is recruiting for a Project Engineer , located in Warsaw, IN .

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 https://www.jnj.com/.

The Project Engineer, Enabling Technologies will be a key supporting role in the team on the forefront of digital technology for the orthopedic medical device industry. This role will support the Enabling Technology R&D team with all aspects of the product development process. The candidate for this role is a strong collaborator that takes the time to understand the project scope in order to drive improvements and efficiently generate technical documentation, standards and procedures.

In this role, you will lead and complete various Enabling Technology and Digital Surgery projects. Emphasis will be on delivering projects on-time, within budget in a compliant and reliable manner.

What Youll Do:

• Understand and follow the New Product Development process accurately.

• Create design solutions applying engineering methods with good documentation processes, generating and releasing design history files in accordance with the company design control process.

• Develop medical device solutions that integrates Software as Medical Device and hardware platforms.

• Uses expertise to improve operational efficiencies and meet compliance requirements.

• Design solutions in a fast pace environment with a quick development cycle, and support those designs with prototype, analysis, and testing results.

• Provide hands-on, problem solving, process and manufacturing support as well as developing, implementing, integrating and testing solutions.

• Must be capable of working independently and in a team while being flexible, self-motivated, curious and willing to revolutionize the world of digital surgery.

Qualifications

Required Education:

• Bachelors Degree in Mechanical Engineering, Electrical Engineer, Biomedical Engineer, Computer Science Engineer, or other relevant technical field.

Required Skills & Experience:

• A minimum of 4 years of product development or design control experience in the Medical Device industry is required.

• Experience in and knowledge of the medical device regulations, including GMP (Good Manufacturing Practices), QSR (Quality Systems

• Regulations) and ISO (International Organization for Standardization) quality requirements is required.

• Flexibility to handle constantly changing requirements and priorities.

• Proven understanding of design control and change control including ISO 13485 and 62304

• Demonstrated ability to prioritize tasks and manage a multifaceted workload is required.

• Proven experience and proficiency using parametric solid modeling and CAD software to design and document parts and assemblies. NX experience preferred.

• Adept at communicating and seeking optimal solutions in a collaborative team environment.

• Must have strong analytical and problem-solving skills, as well as in-depth experience with product development processes.

Other Requirements:

• Ability to travel up to 10% domestic US and Internationally, with overnight stay.

• Ability to work onsite at the J&J office in Warsaw, IN.

Preferred Skills & Experience:

• Strong design experience with a consistent track record in design verification/validation, process verification/validation, and design/process failure modes and effects analyses

• Excellent verbal, written and presentation skills.

• Demonstrated outstanding problem-solving ability.

• Strong organizational and Project Management skills, including MS Project and MS Excel

• Experience working with implantable medical devices.

• Will have working knowledge of related subject areas.

• Experience working in a multidisciplinary team setting bringing products from concept through market release and beyond.

• Knowledge of FDA 510(k) submissions process and regulation controls, and/or IDE clinical studies

Work Environment:

• This position operates in a laboratory/assembly environment. This role routinely uses standard office equipment such as computers, phones, and photocopiers.

Physical Demands:

• May require lifting of up to 50 lbs. and operation of hoisting equipment for heavier loads.

• May require prolonged periods of standing, bending, sitting, and kneeling during system assembly.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporations performance over a calendar/performance year. Bonuses are awarded at the Companys discretion on an individual basis.

• 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 Companys consolidated retirement plan (pension) and savings plan (401(k)).

• This position is eligible to participate in the Companys long-term incentive program.

• Employees are eligible for the following time off benefits:

• Vacation up to 120 hours per calendar year.

• Sick time - up to 40 hours per calendar year.

• Holiday pay, including Floating Holidays up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year.

• Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market."

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 based on disability. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

This job posting is anticipated to close on 7/22/2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

#RADSW

#RADHW

#RADPM

Primary Location NA-US-Indiana-Warsaw

Organization DePuy Synthes Products, Inc (6149)

Relocation Eligible: No

Travel Yes, 10 % of the Time

Job Function R&D Digital

Req ID: 2406199615W