ENG Design Engineer II

Mindlance

San Antonio, TX

JOB DETAILS
SKILLS
Bill of Materials (BOM), Biomedicine, Chemical Engineering, Code of Federal Regulations, Communication Skills, Cost Control, Cross-Functional, Data Analysis, Design Verification, Documentation, Drug Development, Engineering Change Order, FDA (Food and Drug Administration), Failure Analysis, ISO (International Organization for Standardization), Manufacturing, Manufacturing Design, Manufacturing/Industrial Processes, Mechanical Engineering, Medical Equipment, Medical Office Administration, Microsoft Excel, Microsoft Office, Microsoft Product Family, Microsoft Word, Organizational Skills, Performance Analysis, Problem Solving Skills, Product Design, Product Development, Product Engineering, Product Lifecycle, Project Tracking, Regulations, Requirements Management, Risk Analysis, Risk Management, Statistics, Technical/Engineering Design, Test Data, Test Plan/Schedule, Testing, Validation Documentation, Validation Testing
LOCATION
San Antonio, TX
POSTED
8 days ago
PRODUCT ENGINEER II

Summary

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(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.
Skills:
* 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



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

About the Company

M

Mindlance