Job Title - Medical Device Prin Mechanical Design Engineer
Job Location - Miami Lakes, Florida (Onsite)
Type - W2 contract
Technical skills that are required for the role:
SolidWorks CAD advanced to expert users, with an 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.
Must-Have:
Medical device design, development & manufacturing, experience of products with electrical functionality and advantage
Examples of critical thinking and proven project execution
Leading a cross-functional team 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.
Education Required: BSME with 10 years minimum experience, MSME with 7 years minimum experience with Class III devices.
Responsibilities may include the following and other duties may be assigned.
Research, plans, designs, verifies, validates and develops mechanical and/or electromechanical products and systems, such as metals, instruments, instruments, controls, plastics, robots, engines, machines and mechanical, resonance, hydraulic or heat transfer systems for production, transmission, measurement, and use of energy.
Recommends various technological options or approaches for system, processes, facility or program improvements in terms of safety, performance, efficiency or costs.
May be responsible for the transfer from R&D to manufacturing.