We are seeking a Prin Mechanical Design Eng for a very important client.

Responsibilities:

Researches, plans, designs, verifies, validates, and develops mechanical and/or electromechanical products and systems, such as metals, instruments, controls, plastics, robots, engines, machines, and mechanical, resonance, hydraulic, or heat transfer systems for production, transmission, measurement, and use of energy.

Recommends various technology 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.

Specialist Career Stream:

Typically an individual contributor with responsibility in a professional discipline or specialty.

Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results.

May act as a mentor to colleagues or may direct the work of other lower-level professionals.

The majority of time is spent delivering and overseeing the projects from design to implementation while adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

The ideal candidate must possess the following qualifications:

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.

4. Advanced understanding and application of GD&T (Geometric Dimensioning and Tolerancing).

5. Applied Failure Analysis

6. a seasoned SolidWorks Designer

7. Author Design Verification Testing

8. DFMA

9. DRM Design

10. 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.

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.

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.