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R-D Engineer I
6135 Gunbarrel Avenue Boulder, CO 80301 US
Job Description
- Perform Design verification testing in Laboratory environment.
- Update Product Design documentations in moderated changes such as Design History files, V&V testing report and protocols, Product Requirement documents adhering to design controls.
- Makes minor changes in systems and processes to address Quality issues.
Top 3 technical skills that are required for the role:
- 1. Knowledge of Design Verification testing and its documentation.
- Knowledge of Quality, Regulatory requirements, Proficiency in Excel & Word applications.
- CAD – Solidworks.
Education Required:
Mechanical Engineer, Biomedical Engineer, Electrical Engineer.
Years’ Experience Required:
0-1
SUMMARY OF POSITION:
Within the Airways R&D sustaining engineering group, the sustaining engineer’s primary responsibility will be to support Airways disposable medical devices currently on the market. The sustaining engineer will research, test and validate components, materials and applications while sustaining current product designs. The R&D Engineer I is responsible for the design history files, determining test requirements, V&V testing and/or coordinating V&V testing, and design controls. In addition to implementing moderate design changes that either enhance performance or address quality issues, the sustaining engineer supports/ performs complaint investigations, determines root cause failure modes and provides solutions for these product lines.
Responsibilities may include the following and other duties may be assigned. Designs, develops, analyzes, troubleshoots and provides technical skills during research and/or product development. Designs studies to investigate specific life science questions within field of expertise. May be involved in product research and development and/or clinical trials. Translates research discoveries into usable and marketable products.
Generates Engineering Change Orders to support product sustaining efforts.
The R&D Engineer I is responsible for the design history files, determining test requirements, V&V testing and/or coordinating V&V testing, and design controls.
In addition to implementing moderate design changes that either enhance performance or address quality issues, the sustaining engineer supports/ performs complaint investigations, determines root cause failure modes and provides solutions for these product lines.
- Follows strict adherence to policies and procedures associated with an FDA controlled environment.
- Prepares analysis reports for managers, project leaders or other personnel.
- Solid working knowledge of quality and regulatory requirements.
- Works on moderate engineering tasks and has constant feedback from their Supervisor.
- Sustaining engineering MoC programs, product design and project management experience.
- CAD – Solidworks proficiency (3d moldes and 2d drawings).
- Problem solving, priority setting, customer focus and driving for results
- International travel to Design Centers, Manufacturing plants and Contract manufacturing facilities.
- Labeling changes.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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