Resonetics · 10 hours ago
Manufacturing Engineer II
San Diego, CA, US
Full-time
Onsite
Mid Level
$65K/yr - $102K/yr
3+ years expResonetics is a global leader in advanced engineering and micro manufacturing in the medical device industry. They are seeking a Manufacturing Engineer II to support the introduction and industrialization of new life science manufacturing technologies, focusing on New Product Introduction and process optimization.
Life ScienceManufacturingMedical Device
No H1B
Responsibilities
Support the transfer of new products and processes from Process Development into Production, ensuring manufacturing readiness, quality awareness, and product integrity during NPI and early production phases
Introduce and establish manufacturing processes for Nitinol-based medical device components, including laser cutting, shape setting, electropolishing, and inspection operations
Execute and support process validation activities including IQs, OQs, PQs, and Test Method Validations (TMVs)
Review, generate, and maintain process documentation including Work Instructions (WIs), routers, and supporting documentation to ensure alignment with process intent
Assist in establishing initial job cost baselines, cycle times, and ERP standards for new products and processes
Apply structured root cause analysis methodologies, including DMAIC, to investigate NPI issues, early yield losses, dimensional variation, and process instability
Utilize statistical tools and techniques such as Design of Experiments (DOE), process capability analysis (Cp, Cpk), ANOVA, regression analysis, and hypothesis testing to identify key drivers of variation and support data-based decisions
Support early production process optimization efforts including setup reduction, yield improvement, operator training, and process stability enhancements
Provide hands-on technical support during equipment setup, troubleshooting, and qualification activities
Collaborate with Quality and Production teams to support resolution of early-phase NCMRs, deviations, and process risks
Lead assigned NPI and process-related projects by defining scope, tracking actions and milestones, managing risks, and providing clear, data-driven status updates to stakeholders
Serve as a technical point of contact for internal stakeholders and, as needed, customers during NPI and continuation engineering activities
Qualification
Required
Minimum of 3 years of experience in an engineering role within a manufacturing environment, preferably supporting New Product Introduction or process transfer activities
Bachelor's degree in Mechanical Engineering, Industrial Engineering, or a related technical discipline, or equivalent hands-on manufacturing experience
Strong technical writing skills with the ability to generate and maintain process documentation, validation protocols, and reports
Working knowledge of regulated manufacturing environments and quality system requirements
Preferred
Experience within the medical device industry and familiarity with ISO 13485 and Quality System Regulations (QSR)
Hands-on experience with Nitinol processing or other precision manufacturing technologies
Exposure to laser-based manufacturing processes or similar high-precision equipment
Experience applying statistical methods such as DOE, ANOVA, and process capability analysis in a manufacturing environment
Familiarity with Lean manufacturing principles and continuous improvement methodologies
Experience using data analysis or visualization tools (e.g., Excel, Power BI, Minitab)
CAD or SolidWorks experience for basic fixture or tooling support
Company
Resonetics
Resonetics provides laser micromachining contract manufacturing solutions and systems for the life sciences and other high precision.
1001-5000 employees
Funding
Current Stage
Late StageTotal Funding
$1.12BKey Investors
The Carlyle GroupRegatta Medical
2021-12-03Private Equity· $1.12B
2018-02-01Private Equity
2014-10-22Acquired
Leadership Team
Todd Trapp
Chief Financial Officer
D
David Rezac
Global Vice President, AGILE Product Development
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