Job Title: Sr. Project Engineer

Job Description

As a New Product Development Engineer, you will lead major programs involving all phases of product design and development, guiding the Core Team through the execution of project activities. You will follow and improve the Product Development Process to ensure regulatory requirements are met and that the medical device meets its intended use. Your role will involve planning and driving the execution of project activities from initial phases to the final phase of Commercial Release for ongoing production. You will apply the Risk Management Policy to identify hazards, estimate and evaluate associated risks, control these risks, and monitor the effectiveness of risk controls. Additionally, you will guide the project team to use design and technology to drive innovation and significantly improve patient outcomes.

Responsibilities

• Lead major programs involving all phases of product design and development.

• Plan and drive the execution of project activities through applicable project phases to the final phase of Commercial Release.

• Apply the Risk Management Policy to identify hazards, estimate and evaluate associated risks, control these risks, and monitor the effectiveness of risk controls.

• Guide the project team through the use of design and technology to drive innovation and improve patient outcomes.

• Strive for improvement to ensure all applicable aspects of product design including design for manufacturability, scalability, testing, variability, and usability.

• Develop product requirements and design inputs based on applicable standards and other relevant sources such as Post-Market Surveillance.

• Oversee the creation of detailed sub-assembly and final assembly drawings to serve as design specifications for a medical device.

• Develop verification and validation plans for the protocols, test methods, and reports for the execution of design verification and validation testing.

• Navigate completely new medical devices through product requirements, design inputs, design outputs, and verification/validation in a traceability matrix.

Essential Skills

• Experience working in new product development (NPD) and moving the product through the development process.

• Validation and extrusion experience.

• Ability to lead projects, including managing one large project and three smaller ones.

• Experience with Solidworks.

• Mechanical engineering background .

Additional Skills & Qualifications

• BA degree in an engineering-related field.

• 5+ years of experience working in the medical device industry (preferably cardiovascular) focused on New Product Development.

• Experience working with extrusion products.

• Ability to lead and mentor junior team members.

Work Environment

You will be part of a team of six other NPD engineers, half of whom have less than two years of experience. The work environment is fast-paced and involves working on components that go into a finished medical device product. The project you will be focused on is expected to bring in 1.5 million revenue for the company, and the team is set to grow by 12% year over year with strong financial backing.

Pay and Benefits

The pay range for this position is $60.00 - $62.50/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision• Critical Illness, Accident, and Hospital• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available• Life Insurance (Voluntary Life & AD&D for the employee and dependents)• Short and long-term disability• Health Spending Account (HSA)• Transportation benefits• Employee Assistance Program• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Farmingdale,NJ.

Application Deadline

This position is anticipated to close on Mar 24, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.