Job Description
Job Description
ENG Design Engineer II
San Antonio, Tx 78249 United States
Duration: 12+ Months
Client Industry : Healthcare products
Pay rate: $32 - 36/Hr.
Job description:
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 21CFR820 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.
● Detail oriented.
● Excellent understanding of fundamental mechanical principles.
● Organized.
● 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.
● Detail oriented.
● Excellent understanding of fundamental mechanical principles.
● Organized.
● Experience with Microsoft Office Products: Excel, Word, Project.
● Ability to maintain complete confidentiality and discretion in business relationships
Benefits:
Russell Tobin offers eligible employee’s comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), a 401(k)-retirement savings, life & disability insurance, an employee assistance program, identity theft protection, legal support, auto and home insurance, pet insurance, and employee discounts with some preferred vendors.