Job Description
Job Purpose:
At Gilero, our Senior Product Development Engineers lead our mission-driven team with purpose and dedication, fostering inclusivity and teamwork to create innovative solutions for patients and customers. They draw on their experience to oversee and 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. They manage technical risks and ensure high-quality outcomes, ensuring seamless collaboration with customers, vendors and internal teams. They mentor junior engineers, promoting excellence and future success. The work of a Senior PDE should have a sense of pride, characterized by curiosity, attention to detail, and organizational excellence.
Duties:
- 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).
- Technical risk tracking, providing engineering guidance, 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.
- Translate VOC (Voice of Customer) feedback into engineering design inputs and outputs.
- Create/draft clinically relevant User Requirements with minimal oversight
- 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)
- 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
Skills/Qualifications:
- BS in Engineering or equivalent technical degree
- 5+ years relevant experience in product development
- 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.
- 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
- Draft Risk documentation through understanding of Risk, Risk analysis, & Risk Burn Down
- 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 customer
- Commitment to established policies and procedures, while contributing to continuous improvements
- Proficient (or better) computer skills, including Excel and Word
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