Seeking a Project Manager to assist in the design and development of precision-engineered medical devices. Applicants will be expected to lead and contribute as an expert on product design and development with emphasis on intravenous vascular access products.
Candidates must be highly innovative and enjoy working in a dynamic, energetic, and creative environment. A team player and project leader who is looking to excel in a fast-paced, and hands-on environment.
ROLE AND RESPONSIBILITIES
Manage complete projects using technical and administrative skills to oversee and complete engineering tasks of high complexity.
Responsible for managing the complete product design development by leading with unique ideas and solutions to daily problems.
Must monitor and control all aspects of the project(s) assigned with the ability to focus on minor details and high-level goals/objectives.
Establish strong collaboration and rapport with critical and non-critical vendors in the completion of activities impacting their projects.
Lead team of engineer(s) and/or consultant(s) assigned to the project(s) by understanding personal strengths and adapting individual goals, objectives, and responsibilities for on-time and on-budget task completion.
Responsible for mitigating and/or finding solutions to project and product risks to ensure on-time completion of project plans and company goals.
Provide leadership on the development of methods and/or procedures for testing products or systems.
Manage all design transfer activities between engineering and manufacturing by ensuring all processes are scalable, reliable, and meet design output requirements.
Research, assess, and validate the capabilities of equipment and technology used or to be used in the product manufacturing process.
Assist in all facets of regulatory approval process, including leading design reviews, test plan preparation and execution, FDA response activities, etc.
A strong background on statistical data analysis using Minitab.
QUALIFICATIONS
5+ of project leadership experience in a medical device environment of similar product complexity.
Proved track record and experience on all stages of product development including working experience leading biocompatibility studies, sterilization validations, IQ/OQ/PQ validations, Test Method Validations, Design verification and Validation, Human Factors Validation, design specification development, engineering testing (mechanical testing is highly desired with keen understanding on catheter product development).
Good understanding of material selection and plastic injection molding, extrusion, etc.
The candidate must demonstrate leadership qualities by having an on-it mindset and being a humble expert. In addition, the candidate must show keen curiosity and willingness to learn and adapt to the team dynamic such as ability to welcome collaboration, hold yourself accountable, having a positive attitude, and high level of commitment towards your team.
Knowledge of Solidworks, FMEA, tolerance stack analysis, and geometric dimensioning and tolerancing (GD&T) a must but not necessary.
Up to 30% travel domestically or internationally
EDUCATION
BS in Mechanical Engineering or Biomedical Engineering is required. MS or PhD is preferred.