Overview
Skills
Job Details
Pay Range: $55.00 to $65.00 per hour (No PTO, benefits, etc but self funded ACA-compliant healthcare plan available to opt-in to)
Top 3 Technical Skills Required
- Execute Robust Process Development utilizing DOE s, IQ, OQ, PQ
- Problem Solve
- Ability to Write Detailed Work Instructions
Education and Experience
Education Required: BS in Engineering Minimum
Years Experience Required: 4
Work Schedule
Weekly Hours: 40 hours a week
Location: Fully onsite
In this role, you will be part of a team but will be able to work independently with limited supervision to determine and develop approaches to solutions. You will coach and review the work of lower-level professionals. You may manage projects/processes. You will communicate with senior internal and external customers and suppliers. Your work will involve collaboration and dynamic interactions with R&D and Design Assurance regarding products in the development pipeline and with operation team members for new or iterative product implementation. Problems and issues faced are difficult and may require understanding of multiple issues, job areas, or specialties.
Responsibilities
- Process Technologies: Lead the exploration and development of new process technologies that may be incorporated into new product development projects or existing manufacturing lines. Provide in-depth analysis and recommendations on process improvements.
- Process Development: Lead new product development by designing and developing manufacturing processes for new products that facilitate ease of manufacturing while producing quality, cost-effective products with optimized yields. Activities include:
- Manufacturing Studies: Work with engineering team on studies to characterize process inputs to drive development of critical manufacturing/process specifications that are both robust and meet quality expectations. Use appropriate statistical support and Design of Experiments (DOE).
- Equipment and Fixture Development: Identify equipment and fixture needs within pilot line and/or manufacturing operations.
- Documentation: Generate required documentation in support of manufacturing products and processes. These include engineering protocols/reports, PFMECAs, and manufacturing instructions. Ensure compliance with internal procedures, GMP, and regulations.
- Qualification and Validation: Generate and execute plans for equipment qualification and process validation. Lead test method development and validation where needed.
Must Have: Minimum Requirements
- Bachelor's Degree in a related engineering discipline (i.e., mechanical, biomedical, industrial, materials science) with 4-7 years of experience or Advanced Degree with 4 years of experience
Nice to Have
- Previous medical device experience
- Demonstrated problem-solving and critical thinking experience
- Solid oral and written communication skills, including presentation skills
- Solid interpersonal skills and ability to work in a cross-functional team environment
- Solid understanding of statistical techniques and analysis
- Design for Reliability and Manufacturability (DRM) experience
- Demonstrated computer skills such as Minitab, Excel, Word, and Project
- Process Validation (IQ/OQ/PQ) and Test Method Validation experience
Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.
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