Jobs via Dice
Engineer Sr I - Manufacturing - (Mechanical & Electrical) 1
Jobs via Dice, Goleta, California, us, 93116
Overview
Engineer Sr I - Manufacturing - (Mechanical & Electrical) 1 role at Jobs via Dice. Arthrex, Inc. is a global medical device company seeking to provide Manufacturing Engineering support to ACT Production Operations, Quality Engineering, Supply Chain and Product Design teams to achieve business goals. The position is based out of Santa Barbara, CA and is not remote. Arthrex is committed to delivering uncompromising quality to health care professionals and the patients they serve. This role involves sustaining manufacturing engineering, leading projects related to commercialization of new products, process improvements, equipment development and validation, and supporting design transfer and new product development initiatives. Essential Duties and Responsibilities
Define and release manufacturing work instructions to guide assembly operations. Provide production process support for daily manufacturing technical issues. Collaborate with Quality Engineering to meet QMS requirements for medical device manufacturing and ISO-13485. Develop procedures, forms, and instructions for recording, evaluating, and reporting quality and reliability data; perform root cause analysis and corrective actions. Support new product development and design transfer by leading process development and validations, participating in DFx (Design for Manufacturing, Assembly & Test). Drive automation to replace manual processes where economically feasible. Support new product development and project management for mechanical and electrical designs through all design phases. Foster a continuous improvement culture using lean principles to enhance quality, efficiency and cost. Develop and maintain Master Validation Strategies and Plans for component manufacturing, device assembly, and data collection. Lead the design, development and test of new equipment, including gathering user requirements, designing mechanical/electrical systems, coordinating procurement, validation, work instructions, BOMs and operator training. Work with suppliers to determine specifications and arrange for equipment/material purchases; evaluate products against specifications and standards. Draft and execute validation protocols and reports (IQ/OQ/PQ) for equipment and processes. Design, develop, and manage tooling/fixtures; coordinate tooling procurement with suppliers. Perform Gage R&R and Process Capability analyses. Support maintenance of released equipment and tooling through troubleshooting and impact analysis. Introduce and support new equipment, products and processes using standard project management tools and techniques. Understand current manufacturing processes and identify targets for improvements in efficiency, data collection/trending, and SAP work orders. Lead process improvement projects using DOE, Lean Six Sigma (A3, DMAIC) and statistical methods. Ensure data and documentation are accurate and complete; apply statistics to estimate future manufacturing requirements. Analyze and plan workforce utilization, space, and workflow; design equipment layouts using lean practices when feasible. Estimate production times, staffing requirements, and costs to inform management decisions. Stay current with ISO/FDA/ASTM standards and internal quality policies; support audits as a SME. May supervise Technicians or Engineers, or contribute as an individual contributor. Knowledge
Deep understanding and application of engineering principles, manufacturing concepts, and industry practices; strong reasoning ability. Skills
Advanced knowledge of materials and machine design/function. Strong understanding of manufacturing processes and interdependencies; proficiency with industry standard test methods (ASTM). Experience ensuring compliance with ISO 13485 and FDA 21 CFR Part 820 related to cGMP and process validations. Advanced CAD skills; ability to create complex PLC programs (automation roles). Ability to develop Master Validation Plans and to draft/execute complex study protocols, DOE, deviations, and reports. Ability to plan projects using project management tools; prepare capital equipment budgets and ROI justifications. Effective verbal and written communication; ability to coach/mentor junior engineers and technicians. Ability to create and maintain PFEMAs for assigned processes; apply structured problem-solving to improve manufacturing/testing methods. Education
B.S. in Engineering (Mechanical, Electrical, Chemical, or Computer Engineering) required. Minimum 2 years' experience in design and development or manufacturing engineering. Proven experience leading process improvement projects; experience in medical device manufacturing or health sciences preferred. SAP, Minitab, SolidWorks experience preferred; Lean Six Sigma Green Belt/Black Belt certification preferred. Benefits
Medical, Dental and Vision Insurance Company-provided Life Insurance; Voluntary Life Insurance Flexible Spending Account (FSA); Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness) Matching 401(k) Retirement Plan; Annual Bonus Wellness Incentive Program; Onsite Medical Clinics; Free Lunch Tuition Reimbursement; Volunteer PTO; Paid Parental Leave; Paid Time Off; Paid Sick Leave Employee Assistance Program (EAP) All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law. Salary: Goleta, CA; $140,000.00-$200,000.00 Location notes and additional related job listings are provided for context and potential opportunities. Note: This position is based out of Santa Barbara, CA and is not a remote role.
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Engineer Sr I - Manufacturing - (Mechanical & Electrical) 1 role at Jobs via Dice. Arthrex, Inc. is a global medical device company seeking to provide Manufacturing Engineering support to ACT Production Operations, Quality Engineering, Supply Chain and Product Design teams to achieve business goals. The position is based out of Santa Barbara, CA and is not remote. Arthrex is committed to delivering uncompromising quality to health care professionals and the patients they serve. This role involves sustaining manufacturing engineering, leading projects related to commercialization of new products, process improvements, equipment development and validation, and supporting design transfer and new product development initiatives. Essential Duties and Responsibilities
Define and release manufacturing work instructions to guide assembly operations. Provide production process support for daily manufacturing technical issues. Collaborate with Quality Engineering to meet QMS requirements for medical device manufacturing and ISO-13485. Develop procedures, forms, and instructions for recording, evaluating, and reporting quality and reliability data; perform root cause analysis and corrective actions. Support new product development and design transfer by leading process development and validations, participating in DFx (Design for Manufacturing, Assembly & Test). Drive automation to replace manual processes where economically feasible. Support new product development and project management for mechanical and electrical designs through all design phases. Foster a continuous improvement culture using lean principles to enhance quality, efficiency and cost. Develop and maintain Master Validation Strategies and Plans for component manufacturing, device assembly, and data collection. Lead the design, development and test of new equipment, including gathering user requirements, designing mechanical/electrical systems, coordinating procurement, validation, work instructions, BOMs and operator training. Work with suppliers to determine specifications and arrange for equipment/material purchases; evaluate products against specifications and standards. Draft and execute validation protocols and reports (IQ/OQ/PQ) for equipment and processes. Design, develop, and manage tooling/fixtures; coordinate tooling procurement with suppliers. Perform Gage R&R and Process Capability analyses. Support maintenance of released equipment and tooling through troubleshooting and impact analysis. Introduce and support new equipment, products and processes using standard project management tools and techniques. Understand current manufacturing processes and identify targets for improvements in efficiency, data collection/trending, and SAP work orders. Lead process improvement projects using DOE, Lean Six Sigma (A3, DMAIC) and statistical methods. Ensure data and documentation are accurate and complete; apply statistics to estimate future manufacturing requirements. Analyze and plan workforce utilization, space, and workflow; design equipment layouts using lean practices when feasible. Estimate production times, staffing requirements, and costs to inform management decisions. Stay current with ISO/FDA/ASTM standards and internal quality policies; support audits as a SME. May supervise Technicians or Engineers, or contribute as an individual contributor. Knowledge
Deep understanding and application of engineering principles, manufacturing concepts, and industry practices; strong reasoning ability. Skills
Advanced knowledge of materials and machine design/function. Strong understanding of manufacturing processes and interdependencies; proficiency with industry standard test methods (ASTM). Experience ensuring compliance with ISO 13485 and FDA 21 CFR Part 820 related to cGMP and process validations. Advanced CAD skills; ability to create complex PLC programs (automation roles). Ability to develop Master Validation Plans and to draft/execute complex study protocols, DOE, deviations, and reports. Ability to plan projects using project management tools; prepare capital equipment budgets and ROI justifications. Effective verbal and written communication; ability to coach/mentor junior engineers and technicians. Ability to create and maintain PFEMAs for assigned processes; apply structured problem-solving to improve manufacturing/testing methods. Education
B.S. in Engineering (Mechanical, Electrical, Chemical, or Computer Engineering) required. Minimum 2 years' experience in design and development or manufacturing engineering. Proven experience leading process improvement projects; experience in medical device manufacturing or health sciences preferred. SAP, Minitab, SolidWorks experience preferred; Lean Six Sigma Green Belt/Black Belt certification preferred. Benefits
Medical, Dental and Vision Insurance Company-provided Life Insurance; Voluntary Life Insurance Flexible Spending Account (FSA); Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness) Matching 401(k) Retirement Plan; Annual Bonus Wellness Incentive Program; Onsite Medical Clinics; Free Lunch Tuition Reimbursement; Volunteer PTO; Paid Parental Leave; Paid Time Off; Paid Sick Leave Employee Assistance Program (EAP) All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law. Salary: Goleta, CA; $140,000.00-$200,000.00 Location notes and additional related job listings are provided for context and potential opportunities. Note: This position is based out of Santa Barbara, CA and is not a remote role.
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