Advantage Technical · 2 hours ago
Senior Manufacturing Process Engineer
Maple Grove, MN
Full-time
Onsite
Senior Level
$68/hr - $68/hr
5+ years expAdvantage Technical is seeking a senior-level Manufacturing Engineer to lead process development and clinical build line activities in support of new product commercialization. This role will involve owning key process deliverables and collaborating with cross-functional teams to ensure project success.
Staffing & Recruiting
No H1B
Hiring Manager
Damarys Zambrano, MSIOP
Responsibilities
Lead clinical build line activities and support commercialization efforts
Develop and own process characterization and validation documentation
Design, plan, and execute complex engineering tests and experiments
Analyze complex test data, draw conclusions, and communicate results to technical stakeholders
Identify and implement process improvements using appropriate methodologies (e.g., Six Sigma, DOE)
Recommend equipment and process solutions to address technical challenges
Partner with R&D, Process Development, Quality, Production, Regulatory, Equipment Engineering, Supply Chain, and Marketing to ensure project success
Lead cross-functional project teams and manage project goals, timelines, and deliverables
Assess feasibility and technical soundness of proposed processes, products, and equipment
Prepare and present technical reports and documentation
Support new product development and sustaining engineering activities
Complete and manage Capital Equipment Request Authorizations (CERAs)
Identify, implement, and manage production goals and continuous improvement initiatives
Provide technical guidance, training, and direction to operators, technicians, and engineers
Ensure compliance with all quality system requirements and regulatory standards
Build quality into all aspects of engineering and manufacturing processes
Qualification
Required
Bachelor's degree in Engineering (Mechanical, Chemical, Biomedical, or related field)
5+ years of manufacturing or process engineering experience in a regulated industry (medical device, biotech, or similar preferred)
Strong experience in process development, validation, and commercialization support
Preferred
Knowledge of electropolishing processes
Experience with Keyence and Sensofar measurement technologies
Experience with Six Sigma, DOE, and statistical analysis tools
Company
Advantage Technical
Advantage Technical aligns people and companies to create opportunity.
10001+ employees
Funding
Current Stage
Late StageCompany data provided by crunchbase