"Alerted.org

Design Engineer (Experience in Medical Device)

**Location:** Union City, CA **Salary Range:** $80,000 - $95,000 per year

Scope

The Design Engineer will develop and support innovative surgical devices, from concept to launch and beyond, with shared responsibility and shared reward. The role requires a strong understanding of user needs and requirements, the ability to balance individual product-level requirements with system-level requirements, and commitment to resolving complex mechanical design issues while maintaining the highest product quality. Projects will include a mix of new product development, product improvements, and sustaining projects focused on mitigating challenges related to capacity and supply chain issues. Responsibilities include developing, documenting, and validating new product designs, as well as improving existing designs to meet customer needs.

Essential Job Functions

+ **Design and Prototyping:** Creates design concepts and rapidly prototypes physical models (3D printing, machining, etc.) through external vendors.

+ **Intellectual Property:** Creates intellectual property by brainstorming novel concepts, writing invention disclosures, and generating rapid prototypes.

+ **Team Collaboration:** Serves as a technical designer, providing expert technical advice and working on cross-functional project teams to develop new, world-class surgical devices.

+ **Analysis and Improvement:** Performs engineering analyses of parts and assemblies, including FEA (Finite Element Analysis), fatigue analysis, manufacturability assessments, FMEA (Failure Mode and Effects Analysis), root cause analysis, and DOE (Design of Experiments) creation. Establishes and maintains systems for continuous improvement by capturing user feedback and other data.

+ **Documentation & Quality:** Creates and maintains engineering drawings to company and international drafting standards. Supports the quality and regulatory processes by adhering to documentation for product development that aligns with the Quality System, meeting or exceeding requirements of the FDA's **21 CFR Part 820 regulations and ISO 13485 standards** .

+ **Non-Conformance Management:** Works within the non-conformance system to record discrepancies, assists in the review of non-conformance issues, and documents the results of the Material Review Board (MRB) and associated activities.

+ **Testing and Validation:** Performs testing of medical devices to replicate customer complaints and evaluates changes to existing and new product designs.

+ **Manufacturing and Reliability:** Designs for manufacturing and automation, sterilization processes, and biocompatibility. Assesses field reliability data and improves existing product designs as necessary.

+ **Technical Support:** Contacts customers and sales representatives under limited supervision to resolve technical and quality problems and may provide direct technical support.

Minimum Qualifications

Education & Experience:

+ BS in Mechanical Engineering, Biomedical Engineering, or Materials Engineering (or related science/engineering area).

+ **3-5+ years of experience developing medical products (Required).**

+ **Must be highly capable using SolidWorks (Required).**

+ Experience with metals or reusable surgical instruments is a plus.

+ Benefits: Medical, Dental, Vision, Life Insurance, 401(K)

Knowledge, Skills, and Abilities:

+ Skilled in mechanical design and use of **CAD** to create detailed 3D models and engineering drawings.

+ Experience creating rapid prototypes, mock-ups, and evaluating designs via testing and rigorous analysis.

+ Strong mechanical intuition and persistence to drill down to pinpoint the root cause of problems, solving them using fundamental principles.

+ Demonstrated ability to think at a systems level, interface between multiple design groups, and negotiate conflicting requirements.

+ Proficiency using CAD to design parts and assemblies and to create specification drawings in a **PDM (Product Data Management) environment** ; SolidWorks strongly preferred.

+ Familiar and comfortable with concepts of design input, design output, traceability, and risk analysis.

+ Mechanical design and analysis skills, including statics, dynamics, kinematics, strength of materials, and stress analysis (FEA); familiarity with statistics and design of experiments.

+ Experience designing plastic components and assemblies.

+ Excellent interpersonal and communication skills, both written and verbal, and ability to effectively communicate technical issues.

+ Familiar with all phases of the product development lifecycle, including conceptualization, design, verification, validation, and transfer to manufacturing.

+ Proficiency in technical writing.

**Pay Details:** $80,000.00 to $95,000.00 per year

Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to apply

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://uat.adecco.com/en-us/candidate-privacy

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

+ The California Fair Chance Act

+ Los Angeles City Fair Chance Ordinance

+ Los Angeles County Fair Chance Ordinance for Employers

+ San Francisco Fair Chance Ordinance

**Massachusetts Candidates Only:** It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.