Operations Engineer
About The Position
The Operations Engineer will be based out of the in Eden Prairie, MN office and will support a global biomaterial med tech organization. The role is a key member of the engineering team reporting to the Sr. Operations Manager. The Operations Engineer is a primary point of contact for manufacturing projects from new product introductions to continuous improvement projects. The Operations Engineer integrates with other departments on multiple manufacturing projects ensuring that they run to budget and within timelines. This role supports Production, EHS, Operational Excellence and quality functions to ensure coordinated manufacturing of products.
Requirements
- Bachelor’s degree in engineering required.
- Demonstrated knowledge with: Design controls Process validation Equipment design and procurement Safety precautions and protocols for safe handling and the disposal of hazardous agents, re-agents, chemicals and materials Cleaning validations Knowledge of effective engineering problem solving tools QMS change control
- Works independently within established procedures associated with the specific job function.
- Must be able to adjust to shifting and sometimes unexpected priorities and new responsibilities.
- Exceptional organizational, communication (verbal and written) and interpersonal skills.
- Ability to lift and/or carry 50 lbs.
Nice To Haves
- Previous experience in medical device industry and/or medical tech engineering experience preferred.
- Design control/process validation experience preferred.
- Manufacturing Transfer/Line Transfer experience preferred.
- Understanding of Design for Six Sigma, Risk Management techniques, Statistical Analysis methods, and Design of Experiments preferred.
- Advanced degree in technical discipline preferred.
- Experience with transcatheter heart valve manufacturing and/or biomaterials preferred.
Responsibilities
- Supports active manufacturing with a focus on continuous improvement projects and operational excellence.
- Coordinate internal resources and third parties/vendors to ensure execution of projects.
- Ensure that all projects are delivered on time, within scope and within budget.
- Developing project scopes and objectives, involving all relevant stakeholders and ensuring technical feasibility.
- Develop detailed project plans to track progress.
- Measure project performance using appropriate systems, tools and techniques.
- Report and escalate to management as needed.
- Manage the relationship with the client and all stakeholders.
- Perform risk management to minimize project risks.
- Establish and maintain relationships with third parties/vendors.
- Create and maintain comprehensive project documentation.
- Present to the business and key stakeholders as appropriate.
- Liaising with the Commercial and R&D teams as required, providing information for proposal development
- Actively support timely closure of CAPAs, Complaint & audit actions.
- Ensure effective engineering disciplines are followed to deliver launches of new products that can be reliable & repeatedly manufactured.
- Identify potential capacity and operation efficiency opportunities.
- Ensure all activities are performed in accordance with relevant regulations or requirements.
- Any other duties as requested by Senior Management.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
