Prin Mechanical Design Eng
14400 Northwest 60th Avenue Miami Gardens, FL 33014 US
Job Description
Top 3 technical? skills that are required for the role:
- SolidWorks CAD advanced to expert user, with advanced understanding of GD&T.
- Continued and recent design experience with Class III medical devices, including electromechanical envelope packaging of microprocessor controllers, batteries, monitors, and AC/DC Adapters.
- Strong CAPA ownership skills, advanced understanding of FDA Design Controls, failure analysis methodologies, and project management skills.
Education Required:?BSME with 10 years minimum experience, MSME with 7 years minimum experience with Class III devices
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TECHNICAL SKILLS
Must Have
- 1. Medical device design, development & manufacturing, experience of products with electrical functionality an advantage
- 2. Examples of critical thinking and proven project execution
- 3. Leading a cross functional teams and leveraging solid PM skills e.g. project planning, communication, risk management, etc.
- Work collaboratively and with respect & humility with a cross functional team to drive project execution for medical devices, prioritizing safety, quality service, on-time execution.
- Lead team to define goals, provide solutions and align on path forward, drive/track/communicate progress, adapt as needed with team.
- Read and understand quality management system documents that provide details of business processes to be used and comply with those procedures.
- Use scientific problem solving methodologies e.g. DMAIC, process map, 5 whys, Is/Is not, etc.
- Drive solid decision making.
- Attention to detail, accuracy, to ensure own work meets required standard (compliant to quality management system, grounded in scientific facts and/or data, within safety/scope/schedule/cost guidance).
- Understand priority, drive critical path, and monitor secondary critical paths for progress, communicate early any challenges.
- Advanced understanding and application of GD&T (Geometric Dimensioning and Tolerancing).
- Applied Failure Analysis
- a seasoned SolidWorks Designer
- Author Design Verification Testing
- DFMA
- DRM Design
- Experienced in the design of plastic and metal injection molded parts, and of machined metal and plastic parts, for electromechanical enclosures, microprocessor-controllers, batteries, AC/DC Adapter Cables.
Nice To Have
- 10+ years of experience in the medical device industry, with a strong background in field corrective actions, CAPA, or product quality management.
- Solid understanding of FDA regulations (21 CFR Part 820), ISO 13485, EU MDR, and other relevant medical device regulations.
- Proven experience leading FCA and CAPA processes, ideally within a medical device or regulated industry.
- Strong project management skills, with the ability to manage multiple priorities and deadlines.
- Excellent problem-solving and analytical skills, with the ability to identify root causes and implement effective corrective actions.
- Outstanding communication and interpersonal skills, capable of effectively working with cross-functional teams and external stakeholders.
- Proficiency in Microsoft Office Suite and quality management systems (QMS). Strong technical writing capability
- 10+ years of product development with 4+ years product development of medical devices, class III preferred.
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