Senior/Staff Manufacturing Engineer
3 weeks ago
The Manufacturing Engineer is responsible for supporting volume production, new product introductions, designing and validating new product SKU's (IQ-OQ-PQ), developing continuous improvements for assembly processes to achieve company initiatives for commercial success, value creation, and operational excellence. Perform the implementation of design and process improvements, with innovative solutions for product enhancements, cost reduction, and scaling productionAuthor test methods and protocols, perform validation activities and similar qualifications, and generate detailed technical reportsDevelop processing capabilities, and define and author processing instructions that reduce risk and optimize production performancePrototype fixtures using 3-D printers, lathe, drill press, band saw, etcManage vendors for controlled / released components for the GI service providers.Represent Manufacturing on cross functional teams ensuring proper DFMGenerate detailed component and assembly drawings as related to on-market component and fixturing changesDesign, document, troubleshoot and implement new and upgraded equipment/fixturing for ProductionParticipate in supplier selection, qualification, and NCR and CAPA effortsEmphasize quality and utilize a risk-driven approach to ensure compliance to risk management policies and practices and ensure Good Manufacturing Practices (GMP)Contribute to the overall intellectual property position of the CompanySupport company goals and objectives, policies and procedures that comply with FDA Quality System Regulations (QSR), ISO 13485, and any other applicable domestic governing bodies. Actively work to promote team building and morale within the GI department.Required Education and ExperienceMinimum 5- 7 years of related experience in the medical device industry in a manufacturing or operations roleDegree in one of the relevant fields of ME/BE/EEGenerated and managed manufacturing documentation for a commercial medical device product (MPIs, LHRs, BOM, flowcharts, etc.)Capable with Onshape or SolidWorks modeling, engineering drawing generation, DFM, tolerance analysis and tooling designPossess knowledge of process validation, GMP, and state-of-the-art manufacturing processesProven track record using a variety of design tools, prototyping techniques, and evaluation methods to develop, test, and demonstrate the value of new conceptsDemonstrated ability to coach and train production personnelAbility to exercise sound decision-making and good judgment consistent with a senior level positionProficient in the Microsoft Suite, statistical analysis software is a plusLanguages: Full professional proficiency in English is minimum requirement.Preferred Experience and QualificationsExperience in reading and interpreting engineering drawing, specifications, and statistical sampling plans.Experience using dimensional/visual inspection equipment, gage pins, calipers, etcComfortable working in a clean roomAbility to work well under pressure and to meet multiple and occasional competing deadlines while maintaining a cooperative working relationship with other people.Ability to work in a highly detailed environment where mental focus and accuracy of work output is essential.Good organizational and oral and written communication skills, including ability to represent the Company to both internal and external audiences.BENEFITS INCLUDEStock options401(k) program with significant matching contributionMedical/Dental/Vision insurance fully paid for employee15 days PTO + 6 days of sick leave per yearCompany paid for lunches dailyStocked kitchen for drinks, coffee and snacksWork Environment and Personal Protective EquipmentThis job operates in a professional office environment; many of the job's duties may be performed remotely. This role routinely uses standard office equipment such as computers, phones, photocopiers, and scanners. Personal Protective Equipment may be required for assigned work. Work may involve lifting moderately heavy items.Physical DemandsWhile performing the duties of this job, the incumbent is regularly required to be independently mobilePeriods of prolonged sitting or standing at a computer screenOur job titles may span more than one career level. The starting base pay for this role is between $139,000 and $170,000 per year depending on experience. The actual base pay is dependent upon many factors, such as: education, training, transferable skills, work experience, business needs, and location. The base pay range is subject to change and may be modified in the future. This role may also be eligible for equity, benefits and 401(K) with matching.Neptune Medical provides equal employment opportunities to all applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
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