Job Description:
JOB SUMMARY:
The Process Development Engineer is responsible for supporting the development and execution of manufacturing processes for individualized dental products regulated by the FDA that are produced through a Computer Automated Manufacturing Cell or Line. The Engineer assists in defining and documenting manufacturing steps while contributing to automation equipment selection, including robots, conveyors, and PLC-based systems. Working collaboratively with the CAM Development Team, Product Development teams and Product Sustainment teams; the Engineer ensures efficient production, quality standards, and cost optimization while providing hands-on technical support to manufacturing teams.
PRIMARY DUTIES & RESPONSIBILITIES:
Assist in defining manufacturing execution sequences (CAM, CNC, additive manufacturing, tooling, sintering, etc.) based on PFMEA, product and process requirements.
Develop and release documents that will be reviewed and audited by the FDA.
Assist the Quality team as the process SME (subject matter expert) for the released production line during an audit.
Conduct shop floor implementation tests for new and existing manufacturing processes, documenting findings in technical reports.
Provide technical support for production, troubleshooting quality or manufacturing issues and collaborating with cross-functional teams.
Support production teams in optimizing processes and ensuring stable, efficient operations for dental prosthetic products.
Participate in Site Acceptance Tests for new manufacturing processes, ensuring compliance with quality standards.
Conduct pre-study analysis to assess cost/benefit ratios and risk factors for new product launches or process improvements.
Develop documentation and technical drawings related to manufacturing processes and equipment.
Adhere to project timelines and objectives, delivering results aligned with business needs.
Other relevant tasks or duties as assigned by the Process Development Manager.
Some travel (up to 10%) may be required, including internationally.
Job Requirements:
Bachelor of Science in Mechanical or Manufacturing Engineering, or related field.
3+ years of experience in CAD/CAM machining with 5-axis CNC milling machines and related manufacturing processes in a medical device environment.
3+ years in a manufacturing engineering or process development role within a regulated industry, preferably medical devices.
Experience with Process Failure Mode Effects Analysis (PFMEA).
Hands-on experience conducting validations and writing professional test reports.
Must be able to create 3D models and GD&T drawings.
Basic knowledge of equipment qualifications (IQ/OQ/PQ) and process validations.
Understanding of production transfer for new products and manufacturing process development in an FDA regulated environment.
Familiarity with ceramic and titanium processing techniques in manufacturing.
Exposure to statistical tools, lean manufacturing principles, or EBS tools.
PREFERRED QUALIFICATIONS:
Lean/Six Sigma certification preferred.
Experience with root cause analysis and problem-solving methodologies.
Strong communication, documentation, and analytical skills, with the ability to explain technical concepts clearly.
Time management, planning, and organizational skills to handle multiple projects.
Working knowledge of Delcam is preferred.
Proficiency in Microsoft Office (Word, Excel, PowerPoint); experience with SAP or similar ERP systems is preferred.
Openness to sharing knowledge and collaborating with colleagues.
Ability to work both independently and as part of a team, contributing to problem-solving initiatives.
Strong attention to detail, organization, and follow-through in manufacturing projects.
Willingness to work flexible hours to support business needs.
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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.
$81,200 - $121,700Operating Company:
Nobel BiocareEnvista 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.
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What We Do
enVista is a global software and consulting services provider, optimizing and transforming physical and digital commerce for the world’s leading manufacturers, distributors and omnichannel retailers. enVista uniquely optimizes and transforms physical and digital commerce – optimizing supply chain efficiencies to drive cost savings, and unifying commerce to drive customer engagement and revenue. These comprehensive capabilities, combined with enVista’s market-leading Unified Commerce Platform, Enspire Commerce and the firm’s ability to consult, implement and operate across supply chain, transportation, IT, enterprise business solutions and omnichannel commerce, allows mid-market and Fortune 100/5000 companies to leverage enVista as a trusted advisor across their enterprises. Consulting and solutions delivery are in our DNA. Let’s have a conversation.™
