The Senior Process Development Engineer works cross-functionally to lead process development of complex technologies and ensures effective transfer of product into production.
DUTIES AND RESPONSIBILITIES:
- Analyze design specifications and translate the requirements into robust manufacturing procedures to achieve quality and reliability of finished products.
- Assesses process capabilities, prioritizes process improvement opportunities, and implements process improvements on existing manufacturing processes.
- Applies technical knowledge to innovate, design, and develop processes, tooling, and equipment.
- Defines and releases the deliverables as defined by individual design and development plans.
- Defines and releases Process Failure Modes and Effects (PFMEA) analysis, and Master Validation Plans (MVP)
- Defines and releases process characterization, equipment installation, performance and operational qualification (IQ/PQ/OQ) protocols and reports.
- Apply advanced statistical techniques (e.g., Design of Experiments, normality assessment, measurement systems analysis for variable and attribute (destructive/nondestructive) data, means/variance testing) to evaluate process capability, validate measurement methods, and drive data-based decision-making for product and process improvements
- Provides design for manufacturing (DFM) input to the assembly and component specifications.
- Compiles and writes training materials; develops and conducts training sessions.
- Works collaboratively with appropriate departments/teams to develop product design and tooling processes to ensure efficient production methods.
- Interfaces with outside vendors to determine product specifications; coordinates purchase of equipment, materials, and/or parts; evaluates products to ensure they meet specifications and quality standards.
- Estimates production times, staffing requirements, and related costs to provide information for management decisions.
- Estimates future manufacturing requirements and potential.
- Analyzes data for process investigations, productivity improvements, cost analysis, regulatory filings; documents and communicates results.
- Performs other related duties as assigned by management.
Requirements
QUALIFICATIONS:
- BS in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering (or reasonable technical equivalent) and 8+ years of process development/ improvement experience
- Demonstrated cross functional teamwork in technically demanding environment
- Demonstrated ability to develop processes from concept to production
- Highly motivated individual that can independently drive deliverables to completion through collaboration among team members.
- Demonstrated ability to develop and drive innovative solutions into processes and products.
- Understanding of DFM, medical device design control / quality systems and the product development process (PDP).
- Excellent written and oral communication skills
- Strong organizational, problem-solving, and analytical skills
- Ability to manage priorities and workflow
- Demonstrated ability to plan and organize projects
- Good judgement with the ability to make timely and sound decisions
- Creative, flexible, and innovative team player
Preferred Qualifications:
- Working knowledge of data collection, data analysis, evaluation, and scientific method
Benefits
Nextern offers excellent benefits to fuel you in building a fulfilling life & career:
- Employer subsidized health insurance for employees
- Employer paid dental insurance
- Employer HSA contribution
- 401k plan with a company match
- 9 paid holidays (including your birthday!) + PTO and Personal days
- Gym membership subsidy
- Employee Short Term Disability, Long Term Disability, and AD&D Life Insurance
Salary Range for This Position: $100,000 - $120,000.
Nextern is an equal opportunity employer. We encourage applications from candidates of all backgrounds and experiences, and we are committed to fostering an inclusive and diverse workplace. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Top Skills
What We Do
Nextern collaborates with innovators, clinicians, and device partners to create, iterate, optimize and manufacture best-in-class medical devices. We bring an unmatched core competence in medical device product design and development through manufacturing as a leverageable asset to collaborators like you, who are focused on accelerating the commercial side of the business.
