31 applicants
MedTech Healthcare Consultants ยท 3 days ago
Engineering Project Manager
Miami, FL
Full-time
Onsite
Senior Level
5+ years exp
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Hiring Manager
Lauren Clements
Insider Connection @MedTech Healthcare Consultants
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.
Qualification
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Required
5+ years of project leadership experience in a medical device environment of similar product complexity
Proven track record and experience on all stages of product development including 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.
Demonstrated leadership qualities with an on-it mindset, being a humble expert, showing keen curiosity and willingness to learn and adapt to the team dynamic, 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)
BS in Mechanical Engineering or Biomedical Engineering
Preferred
MS or PhD in Mechanical Engineering or Biomedical Engineering
Up to 30% travel domestically or internationally
Company
MedTech Healthcare Consultants
An industry leader in executive recruiting for over 19 years, Action Staffing Services/MedTech Healthcare Consultants is a sought after staffing adviser to a wide variety of companies - both big and small.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase
