Design Engineer II

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This range is provided by Russell Tobin. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$32.00/hr - $35.86/hr

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Duration: 12+ Months

Pay rate: $32 - 35.86/Hr.

The Product Engineer or Sustaining Engineer II will engage with an experienced cross-disciplinary team to support medical device projects.

The Product Engineer II will have the opportunity to participate in product/process change submissions, cost reduction research, product failure investigations, testing, verification and validation, engineering documentation and engineering change orders creation.

The Sustaining Engineer is responsible for driving the Time-To-Resolution of all engineering related issues assigned to him/her either as part of supporting a project in a cross-functional team or as individual contributor.

Duties and Responsibilities:

● Lead design efforts under the guidance of Senior Engineers on design change initiatives.

● Oversee execution of project deliverables as assigned.

● Interface with various departments of company (locally and internationally) to drive projects forward.

● Work with the V&V department to create testing protocols and verification documentation as part of a product design change.

● Become familiar with the medical device development life cycles, manufacturing processes, and technologies.

● Conduct and/or participate in brainstorming sessions to identify creative ideas and unique solutions to current medical device designs.

● Create specifications for device components, assemblies, packaging, and labeling.

● Work with Manufacturing and other Product Development engineers to ensure that products are optimally designed for manufacturing

● Verify that designs meet functional requirements through the performance of engineering analyses and testing.

● Participates in the analysis of risk as part of Risk Management activities as applicable to medical devices.

● Analyze test data using statistical tools, perform in-depth interpretation of results, and generate detailed technical reports.

● Follow Design Control procedures and comply with requirements of 21

CFR
820 Quality System Regulations, ISO 13485 and ISO 14971 as applicable.

● Participates in all reasonable work activities as may be deemed suitable and assigned by management.

Related Education Qualifications

Requires a bachelor’s Degree in Biomedical, Mechanical, Chemical Engineering or similar Engineering disciplines.

Related Experience Qualification:

3 years of experience in the Medical Device industry.

Other Required Qualifications

● Experience as part of internships in regulated design environments a plus – specifically medical device development, Federal Drug Administration (FDA) or ISO registered.

● Ability to communicate effectively, both verbally and in writing.

● Creative thinker and problem solver.

● Motivated and self-starter.

● Excellent understanding of fundamental mechanical principles.

● Experience with Microsoft Office Products:
Excel, Word, Project.

● Ability to maintain complete confidentiality and discretion in business relationships and exercise sound business judgment.

* Experienced creating Engineering Change Plans for medical devices

* Experience with Bills of Materials

● Ability to communicate effectively, both verbally and in writing.

● Creative thinker and problem solver.

● Motivated and self-starter.

● Excellent understanding of fundamental mechanical principles.

● Experience with Microsoft Office Products:
Excel, Word, Project.

● Ability to maintain complete confidentiality and discretion in business relationships

Russell Tobin offers eligible employee’s comprehensive healthcare…