Development Engineer II
Development Engineer II
The Development Engineer II is responsible for managing the commercialization of FDA regulated products from design development through transfer to production. Excellent leadership skills are required to maintain design controls and ensure a program’s success in terms of time, quality, and cost. Strong internal and external communication skills are required to coordinate activities with customers and cross-functional teams.
- Analysis / Reasoning
- Decision making and judgement
- Attention to detail
- Results focused and initiative
- Development and continual learning
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Project Management
- Lead customer meetings as the main technical contact to provide timeline updates, discuss ongoing action items, and establish product requirements.
- Collaborate with internal cross-functional team to ensure customer needs are met.
- Track program schedules and budget
- Oversee customer invoicing
- Problem solve issues that impact budget and schedule
- Collaborate with process engineering and operations to optimize material process flow
- Identify and vet third party suppliers required for project
- Propose design changes to customer that provide cost savings
- Lead design transfer process
- Validation Execution
- Identify and propose product testing plans for validation
- Write process validation protocols and reports for new products
- Generate all supporting documentation for validation and design transfer
- Manage validation trials
- Design Development
- Lead and manage proof of principle trials
- Lead Sourcebook programs by completing strategic sourcing activities. Identify and contact potential suppliers that align with material requirements, and request samples for customer evaluation.
Two or more years’ experience in managing projects highly preferred.
Experience in a medical device environment, and/or material science environment highly preferred.
Two or more years in a manufacturing environment preferred.
OR- Any combination of academic education, professional training or work experience, which demonstrates the ability to perform the duties of the position.
Job Type: Full-time
Pay: $70,000.00 - $75,000.00 per year
- Dental insurance
- Employee assistance program
- Flexible schedule
- Flexible spending account
- Health insurance
- Life insurance
- Paid time off
- Referral program
- Retirement plan
- Vision insurance
- 8 hour shift
- One location
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