Job Details

Principal Product Development Engineer

About our Company

Founded in 2015, M4D LLC is a premier design, developer, and manufacturer of neurovascular medical device technologies. Our mission is to improve and save people's lives by innovating and integrating medical device technologies into marketable therapies. We are passionate about our commitment to manufacturing quality products and proud about our contributions to the healthcare community. Our ability to work creatively and swiftly allows us to continuously innovate and deliver on our mission!

If you are someone looking to make an impact on people's lives, passionate about being innovative, and want to partner with outstanding talent, we would like for you to join us! You would be an excellent fit if you are a self-starter, result-driven, adaptable, highly organized, innovative thinker, enjoy collaboration, and solutions oriented.

Summary of Position

We are hiring a Principal Product Development Engineer to join our team and play a critical role in managing our Process and Transfer department initiatives. This is a permanent, on-site, full-time position based at M4D LLC, Lake Forest, CA. Prior experience working on minimally invasive medical devices and/or associated processing technologies is not necessary but would be advantageous. This position will report directly to the Process and Transfer Manager. Specific duties will be determined and coordinated in conjunction with the corporate needs and strategic plans and will be subject to change given ongoing business and product development needs.

Description

The individual in this role is highly skilled and experienced and can lead and drive the development team. You will be responsible for overseeing the entire product lifecycle, from conceptualization to market release. You will ensure that devices meet all regulatory requirements and maintain the highest quality standard.

Job Responsibilities

• Lead and manage the product development process, from concept through to commercialization, ensuring that projects are delivered on time and within budget.
• Define product specifications and requirements in collaboration with cross-functional teams.
• Conduct thorough risk assessments and implement strategies to mitigate potential issues.
• Collaborate with regulatory affairs and quality assurance team to ensure compliance with all relevant regulations and standards.
• Collaborate with R&D on the creation of prototypes and conduct experiments to determine validity of designs.
• Perform and/or manage design verification, equipment qualification and product and process validation.
• Use CAD software (Solidworks) for part and assembly design and detail drawings.
• Work closely with manufacturing team to facilitate the transition from development to production.
• Manage the budget for product development, optimizing costs while maintaining high product quality and compliance.
• Engage in completing necessary documentations as well as maintaining comprehensive documentation of all product development activities, including design specifications, test results, and regulatory submissions.
• Demonstrate a keen ability to recognize and address problems and challenges as they arise during the product development process and collaborate with the appropriate team to identify and implement effective solutions.
• Utilize written and verbal instructions to ensure the proper assembly and packaging of products.
• Other duties as assigned.

Qualifications

• Bachelor's Degree in mechanical or biomedical engineering or equivalent experience.
• 7 - 10 years industry experience with a medical device company.
• Demonstration of excellent communication (written and oral) skills.
• Demonstration of excellent organizational skills with the ability to adapt to rapidly changing environments.
• Prior experience with non-invasive medical devices (catheters).
• Ability to present/teach detailed technical information to all levels of company personnel and customers.

Physical Requirements

• Extended periods of sitting.
• Extended usage of a microscope.
• Moderate lifting.

Pay Range and Benefits

$130-$150K per year.

Medical Insurance, Dental Insurance, and Vision Insurance, 100% paid for employee.

401K Plan.

Interested in applying? Fill out the attached application and attach with your resume.

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