Job Description:
JOB SUMMARY:
The Sr. Manufacturing Engineer will perform technical leadership and engineering activities to ensure medical device projects comply with applicable regulatory requirements and quality standards. This role focuses on leading complex, cross-functional projects, including establishing new process/operation lines, retrofitting equipment, and supporting audits and regulatory submissions. The Senior Manufacturing Engineer will act as a technical lead for Quality, Manufacturing, EHS, Procurement, Facilities, and Project Management teams. Responsibilities include sustaining and improving current manufacturing operations, leading root cause investigations, and driving continuous improvement initiatives. This position requires strong project management skills, technical depth, and the ability to manage multiple priorities in a regulated medical device environment.
ESSENTIAL DUTIES:
- Lead cross-functional engineering projects to establish new product lines, vendor sourcing and evaluation, procurement of all required components, facility coordination, and SOP development for operator training.
- Lead and execute CAPA, root cause investigations, and process improvement efforts related to cleanroom, shop floor, CNC, labeling, supply chain, and procurement operations.
- Collaborate with molding vendors, leading mold-related improvement projects including mold repair, design enhancements, and validation.
- Collaborate with CNC shop floor for CNC machining improvements, cycle time reduction, SMED events and set up time reduction and process improvement
- Develop and implement manual fixtures, assembly methods, and equipment improvements for manufacturing and labeling processes.
- Retrofitting and innovating equipment such as labeling and capping machines to support operational efficiency.
- Support SAP configuration, router creation, and the development of standardized work instructions and procedures.
- Facilitate and lead Kaizen events and continuous improvement initiatives across various manufacturing functions.
- Assist in all audit activities, including BSI Micro audit, ISO, and regulatory audits, serving as a subject matter expert in manufacturing processes.
- Collaborate with Project Managers on diverse engineering initiatives, learning and contributing to unfamiliar scopes as needed.
- Support of company's strategic plan
- Responsible for designing new processes and improving and maintaining existing processes
- Establish requirements and specifications for these processes
- Use experimental and numerical analysis to evaluate designs, NCMRs, issues
- Identify and mitigate project risks
- Maintain a detailed understanding of division, FDA and ISO regulation, clinical test
- Visit vendors for process improvement, investigation, or process establishment
- Work with project management to develop overall schedule
- Manage time and tasks within schedule
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), and other regulatory requirements
- Maintains positive and cooperative communication and collaboration with all levels of employees, contractors and vendors
- Responsibilities will involve a thorough understanding of Bills of Materials (BOMs), design for manufacturability, process design, process validation, assembly techniques, and design evaluations
- Skilled in drafting protocols and reports related to the development of new processes and the optimization/validation of existing ones
- Skilled in interpreting manufacturing instructions and standard operating procedures, as well as reading, analyzing, and creating engineering diagrams
- Familiar with manufacturing techniques, including manufacturing of implants and small Ti parts
- Support the design, selection, and validation of new tools and equipment
- Evaluate production workflows and metrics, including yield, capacity, and capability
- Offer technical assistance to production and quality teams
- Skilled at solving problems using structured approaches and experienced in breaking down complex challenges into actionable steps
- Create and lead risk assessment activities, such as Process Failure Mode and Effects Analyses (PFMEAs)
- Provide technical support to vendors and suppliers on related issues
- Support cleanroom labeling machine challenges and scraps, including resolving issues with labeling machines, cameras, and PLC systems.
- Generate and submit VD Max Dose Audit and Environmental Monitoring quarterly reports for cleanroom, and any other biocompatibility and cleaning validation reports in support of cleanroom processes and audits.
- Review, provide feedback and approve Change Order documentation.
- Develop and generate engineering protocols/reports and submit Change Orders documentation.
- Participate in Material Review Board activities as needed, perform root cause investigation on NCMRs and help improve the NCMR trend. Respond to Discrepancy Reports for nonconforming products.
Job Requirements:
- Bachelor’s degree in Mechanical Engineering or related engineering field
- 7+ years experience in manufacturing engineering
- 3+ years experience working with SolidWorks program
- Experienced in implementing and sustaining production processes including overseeing processes done at subcontractors
- Must be able to work on-site full-time at our Thousand Oaks facility
- Experience in leading teams or projects with cross functional roles
OTHER SKILLS and ABILITIES:
- Being able to implement AI to maximize productivity and efficiency
- Medical Device experience preferred
- Experience with lean methodologies such as single piece flow, SMED, 5S, visual management, Gemba walk, and quality at the source
- CNC manufacturing methodology and machining methods is required; experience with Swiss machines is a plus
- Injection molding experience is highly desired
- Must be able to fully interpret engineering drawings or blueprints
- Familiar with titanium machining is a plus
- MS Word, Excel, and Outlook experience
- Good communication skills.
- Experience with statistical or six sigma tools such as gage R&R, hypothesis testing, pareto charts, cause and effect diagram, and FMEA is a plus
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Target Market Salary Range:
Actual compensation packages take into account a wide range of factors that are unique to each candidate, including but not limited to geographic location; skill sets; relevant education and certifications; depth of experience; performance; and other business and organizational needs. The disclosed reasonable estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Envista, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. The total compensation package for this position may also include an annual performance bonus, medical/dental/vision benefits, 401K match, and/or other applicable compensation plans.
For Field Sales roles, the salary range listed reflects base pay only and does not include incentive pay opportunities under the applicable sales compensation plan
$117,000 - $143,000
Operating Company:
Implant Direct
Envista and all Envista Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available at: http://www.dol.gov/ofccp/regs/ compliance/posters/pdf/eeopost.pdf.
Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate. Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening. Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.
