Senior Product Development Engineer - Medical Devices

Gilero; Carlsbad (CA); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Annual bonus plan

Medical insurance

Dental & Vision insurance

Life insurance

Disability insurance

401(k) with match

LinkedIn Learning access

Job summary

Gilero in Carlsbad, CA is seeking a Senior Product Development Engineer for medical devices and combination products. Lead design, verification, validation, and DHF activities across the development lifecycle to state-of-the-art requirements.

You will mentor engineers, drive risk retirement, and ensure compliance with QMS, ISO 14971, ISO 13485, and CFR 21. The role emphasizes collaboration with customers, vendors, and internal teams in a fast-paced environment.

Qualifications

• 5+ years of medical device product development experience.
• Experience leading cross-functional teams and projects.
• Knowledge of Phase Gate process and QMS requirements.
• Familiarity with ISO 14971, 13485, CFR 21 and risk management.
• Strong analytical and communication skills.

Responsibilities

• Act as a technical lead for high-complexity product development.
• Manage deliverables through full lifecycle from concept to manufacturing transfer.
• Track technical risk and provide engineering guidance.
• Mentor junior engineers.
• Develop design history files and regulatory submission support.
• Lead test method development and validation.
• Coordinate budgets with project managers.

Skills

5+ years of care product development

Technical leadership

Phase Gate process

Risk management

Analytical skills

Education

BS in Engineering or equivalent technical degree

Tools

GD&T

ISO 14971

ISO 13485

CFR 21

FMEA

Job description

Senior Product Development Engineer - Medical Devices

FullTime Carlsbad, CA, US

5 days ago Requisition ID: 1020

Salary Range: $110,000.00 To $150,000.00 Annually

Do you have a passion for designing and developing innovative medical and drug delivery devices that help improve lives? At Gilero/Sanner's Carlsbad, CA office, we are looking for aSenior Product Development Engineerto join our mission-driven team driving innovative solutions for patients and customers. In this role you will champion the design, development, and production of medical devices and combination devices, focusing on idea generation, verification, validation, and DHF development to state-of-the-art requirements.

If you thrive in a fast-paced, collaborative environment and like ensuing high-quality outcomes working with customers, vendors, and internal teams, this is the opportunity for you. Join us and be part of a company that values innovation, integrity, and excellence!

Responsibilities

• Act as a technical lead, increasing the rigor of technical product development, with project oversight of products, accessories, and cross-functional initiatives.
• Manage product development deliverables of high complexity through the entire development lifecycle, concept through manufacturing transfer (Phase 0 – 5).
• Track technical risk and provide engineering guidance.
• Provide feedback and mentorship to junior engineers.
• Lead the development team through technical risk retirement. Guide the team on technical risks through step-by-step simplification to discover root cause.
• Create, review, and release documents according to Gilero’s QMS and the lifecycle of the project and develop test methods and protocols to fulfill state of the art requirements.
• Inform project managers and business development on technical projects variables in order to build accurate project budgets that include feasibility, prototyping, verification and validation.
• Act as project manager for smaller, technically oriented projects.

Skills/Qualifications:

• Able to work in the office 4 days a week
• BS in Engineering or equivalent technical degree
• 5+ years of product development experience in medical device, combination product or similar space preferred
• Skilled at transforming complex situations into well-defined project deliverables
• Able to lead team to achieve difficult goals through step-by-step simplification
• Able to convert complex questions into tasks to further drive simplification and clarification
• Understanding of good GDP
• Understand the Phase Gate System
• Have deep ISO 14971, 13485 and CFR 21 Knowledge base; Experience with ISO 10993 a plus
• Translate VOC (Voice of Customer) feedback into engineering design inputs and outputs
• Create/draft clinically relevant User Requirements with minimal oversight
• Ability to translate User Needs/Requirements into measurable technical/product requirements and set appropriate specification though thought experiments and empirical testing.
• Ability to discern and document appropriate scenarios for rationale-based decisions versus testing-based approaches
• Ability to author scientific/logic-based rationale
• Prepare documentation to support design history files and regulatory submissions
• Analyze test data, interpret results, formulate conclusions, and apply statistical techniques (t-test, ANOVA, UCL/LCL, Tolerance Intervals)
• Draft Risk documentation through understanding of Risk, Risk analysis, & Risk Burn Down
• Support chartering and maintaining project objectives and milestones.
• Develop testing campaigns, test flows, sample size analysis, and justification, based on sound judgment, Risk analysis, and QMS requirements.
• Lead product and process risk assessments, including hazard analysis, FMEAs and residual risk analysis in conjunction with Quality Engineering
• Write and execute protocols for design verification and validation
• Lead test method development and validation, have strong knowledge of measurement system analysis (e.g. calibration, accuracy, gage R&R, etc)
• Oversee and perform testing and inspection of prototypes and pre-production products including assisting assembly for DV&V builds and clinical builds
• Lead investigation of device failures, coordinate resources, determine root cause, identify corrective actions, and document in conjunction with Quality Engineering
• Investigate, evaluate, and research competitive devices and product materials/designs
• Understanding of Pre-clinical validation and GLP
• Ability to review and understand technical drawings and GD&T to support development lifecycle
• Ability to review, understand, and distill technical standards (ISO, ASTM, IEC, etc)
• Excellent communication skills (oral and written)

Personal Attributes:

• Meets Gilero Core Values:Collaboration - embracing teamwork and transparency in our organization, partnering with our customers and vendors;Integrity - doing the right thing at all times; fair and trustworthy; always keeping the patient in mind;
• Innovation - open to new ideas, processes, and solutions; leveraging technology to creatively solve problems;Excellence - delivering exceptional products and services with passion and pride
• Comfortable and productive in a fast-paced, entrepreneurial environment
• A self-starter seeking a career opportunity with potential for internal advancement, seeking responsibility for core activities and providing high-quality service to internal and to external clients
• Commitment to excellence and quality service to external and internal customers
• Follows established policies and procedures, while contributing to continuous improvements

Eligibility To Work

• Ability to pass a pre-employment background check
• Applicants must be permanently authorized to work in the United States without the need for employer sponsorship now or in the future.
• Gilero does not offer sponsorship for employment authorizations (work visas).
• We are an E-Verify employer and confirm work authorization for all new hires

Why work at Gilero?

Founded in 2002, Gilero, a Sanner Group company, is an international contract engineering firm that specializes in the design, development, and manufacturing of novel medical devices and drug delivery products. At Gilero we are proud of the culture we have built that directly reflects our values of excellence, integrity, innovation, and collaboration. Motivated by our purpose to benefit people and improve patient outcomes, our team continues to grow at a rapid pace. US locations include Carlsbad, CA; Chicago, IL; as well as NC locations in Raleigh, Durham, Greensboro, and Pittsboro.

You will enjoy an annual bonus plan, Medical (3 BCBS plans to choose from), Guardian dental and vision, company provided life insurance, short-term and long-term disability, 401(k) with a match the first month after you start with a zero-vesting period, and access to LinkedIn learning for personal and professional development.