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Sr Engr
17211 Red Hill Avenue Irvine, CA 92614 US
Job Description
*Depending on experience
How you will make an impact:
- Create, test, and/or improve products by developing moderately complex experiments and tests (including writing and executing protocols), analyze results, make recommendations, and develop reports, based on engineering principles
- Driving process and equipment validations (ex. TFIQ, IQ, OQ, PQ).
- Drafting, approving, executing, and maintaining all relevant documentation (ex. SOPs, operator training, specifications, drawings, process sheets, FMEAs, and validation plans).
- Create/update portions of design control documents including requirement specs and risk documents
- Assign R&D support tasks; gives instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work
- Identify, evaluate, manage, and provide guidance to suppliers, including establishing tolerances and defining acceptance criteria for suppliers
- Other duties assigned by Leadership
What you'll need (Required):
- Bachelors degree in engineering or Scientific field & 4+ years' experience -OR- Master's Degree or equivalent in Engineering or Scientific field & 3+ years' experience
- CAD experience (Solidworks -or- Creo)
- Statistical based software (Minitab, JMP)
What else we look for (Preferred):
- Medical Device experience strongly preferred
- Experience in test method development including Fixture development and Validation
- Basic understanding of statistical techniques
- Develop, update, and maintain technical content of risk management files
- Understanding and knowledge of principles, theories, and concepts relevant to Engineering
- Solid problem-solving, organizational, analytical and critical thinking skills
- Good documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
- Ability to interact professionally with all organizational levels
- Ability to manage competing priorities in a fast paced environment
- Ability to build productive internal/external working relationships
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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