Lead Mechanical Design Engineer - Irvine, CA

POSITION: Mechanical Design Engineer, Lead (Principle/Sr. Staff/Staff)

FULLTIME/PARTTIME: Full time, DIRECT HIRE

LOCATION: Irvine, CA

SALARY: Up to $180k/year

(Exact compensation may vary based on skills, experience, and location. Base pay information is based on market location.)

MAJOR RESPONSIBILITIES

*This list is not all inclusive. Additional duties will be assigned as needed.

Essential Duties/Responsibilities

• Design and develop wrist-worn wearable medical devices
• Collaborate with electrical and biomedical engineers to define requirements and understand constraints
• Create engineering drawings, analyses, and reports
• Develop according to medical device regulations, including US 21 CFR 820, ISO 13485, and ISO 14971
• Identify, evaluate, and lead communication with vendors and external design partners
• Design test fixtures for verification testing and assist in writing protocols, reports

Required Knowledge/Skills/Abilities

• Experience with medical device design and development
• Design and modelling of plastic injection molded parts, metal parts, and test fixtures
• Strong design and analysis skills in SolidWorks including Geometric Dimensioning and Tolerancing (GD&T) and Data Management (PDM)
• Working knowledge of CAE (Finite Element Analysis, Computational Fluid dynamics)
• Experience developing and analyzing tolerance stack ups
• Experience with medical device risk management and drafting FMEAs
• Strong technical skills and ability to evaluate and analyze data and results
• Ability to work in a fast-paced environment both independently and in a group setting
• Excellent interpersonal, verbal, and written communication skills in English

Preferred Knowledge/Skills/Abilities

• Experience in the development of wearable devices.
• Understanding of optomechanical design and assembly.

EDUCATION & EXPERIENCE

• Minimum of a Bachelor of Science (Mechanical, BioMedical, Materials, Physics, or similar)
• Minimum 8+ years experience in R&D or Mechanical Design Engineering or equivalent
• Strong Technical skills and ability to evaluate and analyze data and results.
• Experience designing electromechanical assemblies for high volume manufacturing and automation
• Ability to create test protocols to answer critical questions toward wearable product development
• Experience in general lab technique, design of experiments, mechanical/electrical/optical equipment and setups is desirable
• Excellent interpersonal, verbal, and written communication skills
• Excellent computer skills with Microsoft Word, Excel, and Outlook.
• Effective communication skills which include verbal and written in English
• Ability to work in a fast-paced environment both independently and in a group setting with minimal direction the flexibility to adjust to workload based upon changing priorities.
• Time management – the ability to achieve results within expected time periods.
• Problem-solving & critical thinking
• Must maintain a professional/ positive attitude.
• Demonstrate risk assessment and consideration of evidence with every decision, and appropriately prioritizes work.
• Organizational Values: Customers, Results, Innovation, Excellence, Teamwork

#IND1

WORKING CONDITIONS:

• May on occasion be exposed to loud sounds and distracting noise levels, such as from office equipment.
• The ability to lift up to 30lbs
• Use of computers and technology

Here at Canon Recruiting, People are our priority, and we are committed to Include Diversity in every segment of who we are. It is only through our Diversity, we are made a stronger organization, and increase our ability to provide top tier candidates that our clients have come to know Canon for. We have an inclusive environment all employees are celebrated for their unique differences. The different perspectives and experiences of our workforce give us the competitive advantage that is essential for success in an ever-changing market. By promoting inclusion with the same enthusiasm, we devote to quality and competency, and using the experience from a diverse assortment of backgrounds and experiences, Canon is able to improve the services and value we deliver to clients, employees, and customers. At Canon, Diversification and Inclusiveness are much more than a corporate ambition; they are a critical component in our daily corporate life.

Canon Recruiting is committed to a diverse and inclusive workplace. Canon Recruiting is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.

The pay range for this position is listed above. Base pay information is based on market location.

We will consider for employment qualified applicants with arrest and conviction records. Our range of benefits may include health care and 401(k) savings plans.
For individuals with disabilities who would like to request an accommodation, please email our HR department.