Sr Technical Operations Engineer
3 days ago
Position Summary
Uses knowledge of scientific techniques and process excellence to design and develop safe, effective, and efficient processes in support of the company's strategies, goals, objectives, and product portfolio. Provides technical support and oversight to ensure continuity of supply. Leads and participates in complex projects requiring cross-functional support for successful execution.
Duties and Responsibilities
Under limited supervision and in accordance with all applicable government laws, regulations and ASP policies, procedures and guidelines, this position:
- Evaluate manufacturing processes / products and collaborates with R&D, New Product Introduction, Quality Assurance, Manufacturing and Finance teams to lead projects / initiatives to improve quality, productivity and reduce costs. Utilize the application of six sigma and lean tools and methodologies.
- Generate written reports and provide technical expertise to related projects.
- Maintain accurate documentation of concepts, designs, drawings, processes, test methods, data analysis and conclusions or rationales.
- Provide technical support for outside suppliers, vendors, and/or consultants as required, inclusive of supplier visits and identification / implementation of process improvements.
- Work out proposals and cost estimates of project/process related costs or cost improvements.
- Provide guidance and work direction to fellow engineers and related project team members.
- Responsible for communicating business related issues or opportunities to next management level
- Performs other duties assigned as needed
Knowledge, Skills, Abilities, Certifications/Licenses, and Affiliations:
(Include any required computer skills, regulatory knowledge, certifications, licenses, languages, cognitive and behavioral abilities etc.)
- Verbal and written communication skills
- Project management
- Business/financial acumen
- Six sigma and process excellence tools/methodologies
- Presentation skills
- Knowledge of FDA and other regulatory guidance preferred.
- Proficiency in Microsoft MS Office is required
- 3D Modeling Software experience preferred. (Solidworks, Ideas, etc)
- PCB Design Software experience preferred. (OrCAD, Altium, etc)
Qualifications
Bachelor's Degree in an Engineering Field - Mechanical, Electrical, Manufacturing, or Process preferred.
4-5 Years of Manufacturing or Medical Device experience required.
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