Npi Engineer
hace 2 semanas
By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success.
At Integer, our values are embedded in everything we do.Customer
We focus on our customers' success
Innovation
We create better solutions
Collaboration
We create success together
Inclusion
We always interact with others respectfully
Candor
We are open and honest with one another
Integrity
We do the right things and do things right
Who are we?
Job Summary:
The Engineer will be expected to provide hands on engineering support to internal and external customers. Interacts with customers and provides support for Engineering and Quality Systems.
Coordinates and exercises functional authority for planning, organization, control, integration, and completion of Engineering activities within area of assigned responsibility.
Accountabilities & Responsibilities:
- Follows and develops Quality and Regulatory requirements including policies, procedures, and appropriate regulatory requirements.
- Plans, Develops, and Executes Master Validation Plans, Process and Test Method Validations (IQ, OQ, PQ, PPQ) in accordance with procedures and guidelines.
- Prepares or reviews documentation with a high degree of accuracy, completeness, and effectiveness using common engineering tools & templates were available. (Examples include specifications, manufacturing procedures, ECOs, and technical reports or analysis).
- Applies and Promotes Lean manufacturing techniques to continuously improve cycle times and process flows. Identifies, supports, or directs the execution of improvement efforts to reduce waste in all manufacturing and business processes.
- Plans, executes and manages project activities with cross functional teams. Project types can include new product development and introduction, manufacturing transfers, continuous improvement and cost reduction initiatives.
- Applies and leads DMAIC
- Six Sigma approaches to solve issues and reduce variation in all manufacturing and business processes.
- Demonstrates leadership through mentoring of junior staff and responsiveness to business needs to achieve positive results.
- Follows and develops Quality and Regulatory requirements including policies, procedures, and appropriate regulatory requirements.
- Plans, Develops, and Executes Master Validation Plans, Process and Test Method Validations (IQ, OQ, PQ, PPQ) in accordance with procedures and guidelines.
Education & Experience:
- Minimum Education: Bachelor of Science in Engineering (Mechanical Engineering, Industrial Engineering or related)
- Minimum Experience: Minimum of 5 years of experience (2+ years in medical device industry, preferred), including: engineering, manufacturing, product/lines transfers, new product launch, equipment installation and validation. Post graduate studies in technical field are a plus.
Knowledge & Skills:
- Demonstrated ability to follow and develop both Quality and Regulatory requirements.
- Proven track record of proactively managing risk to achieve business and customer objectives.
- Excellent communication skills, strong customer relationships, leadership skills and team building competencies.
- Ability to work to a deadline and to handle multiple tasks simultaneously.
- Excellent problemsolving skills are required. Uses structured problemsolving techniques and statistical methods for data driven analysis and decisions
- Proven skills on equipment with solid knowledge of pneumatics, hydraulic, automation, PLC, robotics.
- Management of laser equipment, plastic presses, temperature process, electric/electronic production test equipment.
- Demonstrated skills on production measurement equipment.
- Proven Management of CAD software or mechanicals parts design.
Specialized Knowledge:
- Proven Management of CAD software or mechanicals parts design.
- Medical device manufacturing industry experience, preferred.
- Knowledge of program management.
- Knowledge of product line transfer, including site to site and customer to site. From planning, timeline management and successful execution.
- Knowledge of new product introduction, including planning, equipment acquisition, process development and line layout.
- Knowledge and assurance of EHSS and Ergonomic requirements.
Other:
- English 80%, fluent on speaking, listening, writing, reading.
- Six sigma green belt and/or lean certified, desirable.
- Up to 25% travel.
- Experience with Microsoft Office including Microsoft Word, Excel, PowerPoint, Project, and Minitab.
S Applicants:
EOE/AA Disability/Veteran
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