New Product Introduction Project Manager

Well Established Class 2 implantable device manufacturing operation in Carlsbad seeks a proven Medical Device NPI Project Manager to lead a broad mix of NPI Projects. Ideal candidates would have experience from the Orthopedic, Spine, or Dental Implant Manufacturing industry. Smaller P.E owned organization with nimble decision making and ambitious growth plans. Excellent benefits and a highly collaborative team. This person direct the activities of 4-5 team members in the execution of a varied NPI agenda.

This role is responsible for the comprehensive project management of all Research and Development projects as well as the management of the design engineering team. This position involves leading cross-functional product development teams and overseeing the progress of teams led by design engineers. A key aspect of the role is maintaining and enhancing the quality system processes within Design Engineering's responsibilities and ensuring that all direct reports adhere to company policies and procedures.

Essential Job Duties and Responsibilities:

• Project Management:
• Maintaining up-to-date status reports of all active R&D projects for review by upper management.
• Coordinating core team activities effectively.
• Designing, thoroughly documenting, obtaining necessary approvals for, and conducting all testing related to new product development, as well as testing required for existing product support.
• Ensuring adherence to design control processes throughout project lifecycles.
• Creating and maintaining design history and technical files.
• Managing project timelines to ensure on-schedule completion.
• Taking ownership of achieving project milestones.
• Ensuring overall project success through effective leadership and management.
• Contributing to the development and creation of intellectual property.
• Designing parts and/or systems utilizing 3D CAD software.
• Providing essential engineering support for regulatory submissions.
• Offering crucial engineering support for both production and quality assurance processes.
• Management Responsibilities:
• Overseeing the technical aspects and project management of product development initiatives.
• Identifying, suggesting, and implementing improvements to internal processes.
• Developing the expertise and skills of direct reports in both engineering and project management domains.
• Collaborating effectively with upper management on strategic initiatives and project updates.

Education, Experience, Skills, & Abilities:

• Bachelor's degree in Engineering is required.
• Minimum of 7 years of relevant engineering experience.
• Demonstrated strong project management skills.
• Proven ability to effectively lead product development team members.
• Successful track record of leading cross-functional teams in the development and commercialization of new products.
• Proven ability to drive projects forward and motivate team members to achieve goals.
• Excellent written and verbal communication skills are essential.
• Strong organizational skills, attention to detail, precision, and accuracy are required.
• Previous experience with engineering design and testing is necessary.
• Prior experience with cGMP/ISO in the medical device industry is highly desired.
• Previous experience in designing and/or maintaining cGMP/ISO-compliant Quality Systems is a plus.
• SolidWorks 3D CAD experience is desired.
• Experience with various manufacturing processes, including plastic injection molding, metal part fabrication, and coating processes, is beneficial.
• Familiarity with the use of a variety of inspection measurement equipment is desired.
• Dental industry experience is preferred.