Nextern · 4 hours ago
Senior Process Development Engineer
Maple Grove, MN
Full-time
Onsite
Senior Level, Lead/Staff
$100K/yr - $120K/yr
8+ years expNextern is a company that focuses on leading process development of complex technologies. The Senior Process Development Engineer will work cross-functionally to ensure effective transfer of product into production and will be responsible for analyzing design specifications, implementing process improvements, and collaborating with various departments to ensure efficient production methods.
Health CareManufacturingMedical
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
Qualification
Required
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
Working knowledge of data collection, data analysis, evaluation, and scientific method
Benefits
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
Company
Nextern
Nextern is a collaborative medical device company with innovators, clinicians, and device partners.
501-1000 employees
Funding
Current Stage
Late StageLeadership Team
John Hastings
Chief Executive Officer
R
Rich Farrell
Executive Chairman
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