Prin Mechanical Design Eng - Exempt

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.

JOB DESCRIPTION

See Technical Skills Must Have's & Nice to have's in the Job Requirements above

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

Years' Experience Required: see above

Will the contractor be working 40 hours a week? If not, weekly estimate? 40 hours/week

Does this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like? Onsite 3 days/week minimum, up to 5 days/week.

What is your timeline for scheduling interviews? Beginning January 6 2024

What product line will this person support? HVAD

Responsibilities may include the following and other duties may be assigned. 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 and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). DIFFERENTIATING FACTORS Autonomy: Recognized expert, managing large projects or processes . Exercises considerable latitude in determining deliverables of assignments, with limited oversight from manager . Coaches, reviews and delegates work to lower level specialists. Organizational Impact: Contributes to defining the direction for new products, processes, standards, or operational plans based on business strategy with a significant impact on work group results . May manage large projects or processes that span outside of immediate job area. Innovation and Complexity: Problems and issues faced are difficult, moderately complex and undefined, and require detailed information gathering, analysis and investigation . Develops solutions to moderately complex problems, and/or makes moderate to significant improvements of processes, systems or products independently to enhance performance of job area. Implements solutions to problems. Communication and Influence: Represents organization as a primary contact for specific projects and initiatives; communicates with internal and external customers and vendors at various levels . May negotiate with others to reach understanding or agreement, and influence decisionmaking. Leadership and Talent Management: Typically provides guidance, coaching and training to other employees within job area. Typically manages major / moderately complex projects, involving delegation of work and review of work products, at times acting as a team leader. Required Knowledge and Experience: Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience. May have broad knowledge of project management. Requires a University Degree and minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.