Senior Product Development Engineer

OVERVIEW:

Our client, a US Fortune 250 company and a global medical technology corporation serving customers in Clinical Labs, Health care research & Pharmaceutical industry, seeks an accomplished Senior Product Development Engineer.

Position: Senior Product Development Engineer

Location: San Diego CA 92121

Duration: 12 Months Contract with possible extension

Pay Rate: $50/hr - $56/hr (depending on experience)

Relocation Expenses/ Assistance: NO

Job Description:

• Research and Development Engineering is responsible for development and lifecycle management of products through medical device design control processes and good engineering and documentation practices.
• Demonstrates working knowledge of Engineering principles and its application in solving standard technical problems.
• Demonstrates working knowledge of product design, development, and design control process.
• Develops technical plans for design inputs and outputs, conducts analytical and empirical feasibility studies, develops test methods to verify and validate subsystems and systems in order to transfer designs alongside Manufacturing.
• Demonstrates knowledge to provide design documentation to support global Regulatory filing strategies.
• Applies basic statistical techniques and utilizes design of experiments with moderate guidance. Collaborates within a cross-functional team to plan, develop, modify, implement, and support products through the application of rigorous engineering practices. Works with moderate guidance to achieve project objectives.
• Flexible work arrangements allow our team members to collaborate remotely and onsite to experiment, discover, create, and simply connect with others toward a common purpose.
• R&D engineers are responsible for leading and supporting projects as part of a cross-functional global team.
• This is a highly collaborative position and requires excellent leadership, verbal, and written communication skills. Projects will involve requirements definition, developing test methods, writing test protocols, reports, executing verification testing, solving test or design issues and other types of mechanical engineering activities.
• Lead R&D deliverables throughout the medical device design control process for intravenous infusion sets and connection devices.
• Collaborate within a cross-functional team to plan, develop, modify, implement, and support ISD products through the application of rigorous engineering practices
• Engineer robust products through strong understanding and application of engineering fundamentals and DFSS principles.
• Develop technical plans and guide the team to develop design inputs, conduct analytical and empirical feasibility studies, refine product configurations and designs, verify and validate subsystems and systems, concurrently transfer designs alongside Manufacturing and Operations, and provide design documentation to support global Regulatory filing strategies
• Execute design verification testing to confirm design outputs meet design input requirements.

Required Qualifications:

• BS – Mechanical Engineering, Materials Engineering or Biomedical Engineering
• Work experience 5 years or 3 years plus an advanced degree
• Experience with medical device design control processes and creating and maintaining design control documentation.
• Critical thinking – able to work with moderate guidance in own area of knowledge.
• SolidWorks or equivalent CAD tool
• Ability to manage multiple projects of varying scopes in parallel.
• Ability to work leading or as part of a cross-functional team with members from marketing, sales, clinical, regulatory, medical affairs, quality, manufacturing, etc.
• Experience with medical device design control processes and creating and maintaining design control documentation.

I'd love to talk to you if you think this position is right up your alley, and assure a prompt communication, whichever direction. If you are looking for rewarding employment and a company that puts its employees first, we'd like to work with you.

Sajag Bhardwaj

Job Types: Full-time, Contract

Salary: $50.00 - $56.00 per hour

Expected hours: 40 per week

Benefits:

• Health insurance

Experience level:

• 5 years

Schedule:

• 8 hour shift
• Monday to Friday

Education:

• Bachelor's (Required)

Experience:

• Medical Devices: 3 years (Required)
• Lifecycle Management: 2 years (Required)
• Change Assessments: 2 years (Required)
• Supplier Qualification: 2 years (Required)

Ability to Commute:

• San Diego, CA 92121 (Required)

Work Location: In person