Design Engineer (Experience in Medical Device)

Role details

SCOPE:

The Design Engineer supports the development of innovative surgical devices from concept through product launch and post-market support. This position is responsible for understanding user needs and product requirements, balancing product-level and system-level requirements, resolving mechanical design challenges, and maintaining a strong commitment to product quality. Projects will include new product development, product improvements, and sustaining engineering activities, including initiatives related to manufacturing capacity and supply chain challenges.

Responsibilities include designing, documenting, testing, and validating new products, as well as improving existing products to meet customer and business needs. The Design Engineer is also expected to develop a thorough understanding of product construction, functionality, durability, wear, and potential failure modes. As needed, this position will provide technical and hands-on support for repair and quality inspection activities. Knowledge gained through these activities will be used to support product development, root cause investigations, and continuous improvement.

. ESSENTIAL JOB FUNCTIONS

• Develops design concepts and coordinates with internal resources and external vendors to create rapid prototypes and physical models using 3D printing, machining, and other appropriate methods.
• Contributes to the development of intellectual property by generating novel design concepts, supporting invention disclosures, and developing prototypes.
• Works as a technical contributor on cross-functional project teams to develop new and improved surgical devices, collaborating with Design Engineering, Quality, Regulatory, Manufacturing, Marketing, and other functions as appropriate.
• Performs engineering analyses of components and assemblies, including Finite Element Analysis (FEA), fatigue analysis, manufacturability assessments, Failure Mode and Effects Analysis (FMEA), root cause analysis, and Design of Experiments (DOE), as appropriate.
• Uses user feedback, field data, test results, repair information, and other relevant data to support continuous improvement of existing and new product designs.
• Creates and maintains engineering drawings in accordance with company requirements and applicable international drafting standards.
• Supports Quality and Regulatory activities related to new and existing products.
• Prepares and maintains product development documentation in accordance with the company's Quality Management System and applicable regulatory requirements, including FDA requirements and ISO 13485.
• Participates in the nonconformance process, including documenting discrepancies, supporting investigations and reviews, and documenting Material Review Board (MRB) decisions and related activities.
• Reviews Device Master Records (DMRs), Device History Records (DHRs), and other quality-related documentation for accuracy and completeness.
• Supports First Article Inspection (FAI) activities as needed.
• Performs testing and engineering evaluations of medical devices, including testing to replicate reported customer complaints and evaluate proposed changes to existing and new product designs.
• Incorporates Design for Manufacturing (DFM) principles into product designs and considers manufacturing processes, automation, sterilization requirements, and biocompatibility, as applicable.
• Reviews field reliability and product performance data and recommends improvements to existing product designs as appropriate.
• Supports the technical evaluation and investigation of customer complaints related to product design, functionality, durability, and performance.
• Participates in the evaluation of nonconforming products and identifies opportunities to improve existing and new product designs.
• Provides technical support to Repair Technicians as needed to evaluate product construction, functionality, durability, wear, and failure conditions. Uses findings from repair activities to improve product knowledge and identify opportunities for design improvements.
• Supports Quality Inspection activities as needed to evaluate product specifications, workmanship, functionality, and potential quality issues. Applies knowledge gained through inspection activities to support product development, root cause investigations, and continuous improvement.
• May assist with hands-on repair and quality inspection activities when necessary to support business needs, product investigations, and engineering evaluations.
• Analyzes product repair and service data to identify potential design improvements for new and existing devices.
• Under the direction of the Assistant Manager, Design Engineering, communicates with customers, sales representatives, suppliers, and internal teams as needed to investigate and resolve technical product issues and provide engineering support.
• Performs other duties and engineering activities as assigned by management.

PHYSICAL REQUIREMENTS

The physical demands described here are representative of those that must be met by an employee to successfully perform essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Duties are performed while sitting at a desk, walking, bending, squatting, lifting, carrying, pulling and pushing within the office area and warehouse will be required as needed on a daily basis. Required duties include operating a computer frequently (about 85% of the time), reading, writing and communicating email correspondence (about 60%), and using a telephone (about 10% of the time).

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Job duties are performed in an office and wharehouse environment utilizing standard office equipment such as a computer, and telephone. The noise level in the work environment is usually low to moderate.

MINIMUM QUALIFICATIONS

- The qualifications below are the knowledge, skills, and abilities required to do this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

KNOWLEDGE, SKILLS, AND ABILITIES:

• BS Mechanical Engineering, Biomedical Engineering, or Materials Engineering (or related science/engineering area)
• 5+ years of experience developing medical products. Experience with metals or reusable surgical instruments is a plus
• Must be highly capable using SolidWorks'. Skilled in mechanical design and use of CAD to create detailed 3D models and engineering drawings. Must be highly capable of using SolidWorks
• Experience creating rapid prototypes and mock-ups and evaluating designs via testing and rigorous analysis
• A passion for solving tough technical problems - Strong mechanical intuition and persistence to drill down to pinpoint root cause of problems, solving problems 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 environment; Solid works strongly preferred
• Hands-on engineering with the ability to work well in a team environment
• Comfortable with all phases of the product development lifecycle including design, implementation, debug, verification, qualification, and transfer
• 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 Finite Element 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 phases of the product development lifecycle, including conceptualization, design, verification, validation, and transfer to manufacturing
• Proficiency in technical writing

TRAVELS This position may require 10 to 20% of time to meet with customers.

Job Types: Full-time, Permanent

Pay: From $100,000.00 per year

Benefits

• 401(k)
• 401(k) matching
• AD&D insurance
• Dental insurance
• Disability insurance
• Employee assistance program
• Flexible schedule
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Referral program
• Retirement plan
• Tuition reimbursement
• Vision insurance

Education

• Bachelor's (Preferred)

Experience

• developing medical products: 3 years (Required)
• SolidWorks: 2 years (Required)

Ability to Commute:

• Union City, CA 94587 (Required)

Work Location: In person