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Sr Manufacturing Engineer
5920 Longbow Drive Boulder, CO 80301 US
Job Description
Pay 45-60 depending on experience
Top 3 technical skills that you are looking for in a candidates experience:
- Process Validation
- Design of Experiments
- Gauge R&R
- Bachelors of Engineering degree (Mechanical, Electrical, Software or Bio-Medical)
Nice To Have
- 1. Investigation and root cause analysis skills, 2. Technical writing knowledge, 3. Organization and Communication skills, 4. Process Validation and Computer software validation knowledge
- • Ability to use statistical techniques to analyze data
- Automation
- design of experiments
- Gauge Repeatability and Reproducibility
Education Required: Bachelor’s Degree in a technical discipline
Years’ Experience Required: Minimum 4 years
This position is for an Advanced Manufacturing Engineer. This role will support a lead manufacturing engineer during development and validation of new production lines. Responsibilities include, but are not limited to:
- Support development and validation for new production equipment.
- Develop and characterize the manufacturing process window and secure process capability across all variation in production materials and processes.
- Develop and execute plans, including statistical analysis, to evaluate process repeatability through equipment qualification and process validation (IQ/OQ/PQ).
- Define and generate all required documentation in support of manufacturing protocols, reports, changes, and manufacturing instructions. These include Engineering protocols, reports, process risk documents (PFMEA), manufacturing instructions, change orders and statistical analysis.
- Provide engineering support to manufacturing operations and address quality issues arising on the production floor.
Minimum Requirements
- Bachelor’s Degree in a technical discipline
- Minimum 4 years of experience required.
Nice to Have
- Master’s Degree in a technical discipline
- Medical Device and/or Manufacturing Experience
- Experience in a medical device manufacturing environment
- Experience developing vision inspection/verification systems
- Experience with equipment development and process validation (IQ/OQ/PQ)
- Experience working with statistical analysis tools to include Minitab, DOE, process capability, measurement system and confidence interval analysis
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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