Envista

Mechanical Engineer III

United States of America, Pennsylvania, Quakertown · Mid

Sponsorship not specified$116k-$141kDetected 13 hours ago

Code ReviewProject ManagementExcelSupply ChainRecruitingHRCustomer SupportSolidWorksCreoMechanical DesignGMPFDA RegulatoryMedical DevicesLeadershipCommunicationCollaborationProblem SolvingMentoringMicrosoft OfficeRegulatory Affairs

About the role

Job Description: DEXIS is looking for individuals who work their best, help others, and commit to helping us improve our customer lives and celebrate the difference in others.
Who is DEXIS and why should you join the team??
The facility has a growing, energetic, and diverse mix of professionals spanning engineering, operations, regulatory and quality backgrounds that work collaboratively in the fast-paced medical device field.

Responsibilities

Leads or supports engineering projects from initial concept and project specification through design, prototype build, verification, design transfer, manufacturing implementation, and post-launch support.
Develops mechanical designs, assemblies, components, fixtures, tooling, and related specifications while balancing safety, reliability, manufacturability, serviceability, cost, and user needs.
Prepares and maintains engineering documentation for multiple audiences, including design inputs, design outputs, drawings, bills of material, test protocols, test reports, engineering analyses, ECNs, and design history file content as applicable.
Participates in and may lead cross-functional design reviews, FMEA activities, risk analysis, usability or human factors reviews, troubleshooting sessions, and technical decision reviews.
Develops verification strategies and writes or reviews test protocols for mechanical products, components, assemblies, fixtures, and design changes.
Performs hands-on testing, prototyping, troubleshooting, root-cause analysis, and design iteration using engineering judgment and data from multiple sources.
Interprets legacy designs and performs sustaining engineering activities, including product support, component obsolescence resolution, supplier changes, value engineering, and continuous improvement.
Interfaces with manufacturing, subcontractors, suppliers, and international design teams in design transfer, technical support, and vendor coordination situations.
Designs, fabricates, or coordinates test parts, equipment, jigs, and fixtures using internal resources, suppliers, basic machine tools, and rapid prototyping methods as appropriate.
Prioritizes and manages multiple projects or activities with limited supervision, elevating risks, tradeoffs, and resource needs in a timely and professional manner.

Requirements

Bachelor's degree in Mechanical Engineering or equivalent technical discipline.
an advanced degree may be considered in combination with relevant experience
Demonstrated ability to independently complete complex engineering assignments with minimal guidance and to make sound engineering recommendations based on data, analysis, risk, and business needs.
Hands-on experience with testing, prototyping, troubleshooting, root-cause analysis, and verification of mechanical designs, products, or fixtures.
Proficiency with Microsoft Word, Excel, PowerPoint, and standard engineering documentation practices.
Demonstrates readiness for future people leadership by showing consistency, composure, documentation discipline, prioritization, and the ability to influence outcomes without formal authority.
10+ years of relevant experience in mechanical product design, sustaining engineering, new product development, design transfer, manufacturing support, or a closely related engineering role; an advanced degree may be considered in combination with relevant experience; experience in a regulated industry such as medical device, aerospace, or automotive is highly desired
Strong working knowledge of mechanical parts, assemblies, mechanisms, materials, tolerancing, drawings, specifications, and design for manufacturability.
Proficiency with 3D CAD and 2D drawing tools such as SolidWorks preferred, Creo, or equivalent.
Working knowledge of design control documentation, engineering change control, risk-based decision making, and cross-functional product development practices.
Demonstrated ability to lead small to moderate technical workstreams, coordinate cross-functional input, mentor less-experienced team members, and influence without direct authority.
Strong written, verbal, and interpersonal communication skills, including the ability to explain technical information clearly and build consensus in complex or sensitive situations.

Nice to have

Experience with Design Control, DFM, GMP, FDA, ISO 9001, ISO 13485, risk management, or related quality system requirements.
Intermediate to strong knowledge of materials and associated processing techniques, including plastic injection molding, CNC machining, sheet metal forming or stamping, casting, and additive manufacturing.
Experience with FMEA, fault tree analysis, risk analysis, usability or human factors considerations, component selection, reliability principles, value engineering, and design for assembly.
Experience with basic machine shop equipment, 3D printing equipment, prototype fabrication, and fixture development.
Formal project management, technical leadership, Lean, EBS, or continuous improvement training.
depth of experience
and other business and organizational needs.
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.

Compensation

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.
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.
$115,700 - $141,400

Benefits

PTO, Sick Time and Paid Holidays.
Competitive leave policies including but not limited to Sick, Jury Duty, Bereavement, Personal, and Parental Leave Medical, Dental, and Vision Insurance Benefits effective DAY ONE!!!!
Newly built 1200 sq fitness room.

Company info

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 not pay a fee to any Agency that does not have such agreement and written approval in place.
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.
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.

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