R&D Engineer II, Device Design Control
As a key member of our Development, Technology & Engineering team, the R&D Engineer II, Device Design Control is responsible for generating the inputs and organizing, collating and authoring technical documents (e.g. technical reports, etc). Working as part of cross-functional Device Design project teams through all phases of the design development process supporting the execution of project activities through product launch.
Responsibilities include developing the content and format of Medical Device and Combination Product Design History File (DHF) documents such as Lab Notebook, Design & Development Plans, Design Verification and Design Validation Protocols and Reports, Risk Assessments, and Trace Matrices. Responsible for developing and testing solutions to solve technical problems. The role will involve project team responsibilities and include generating data, writing and assembling device engineering related documents for an NDA submission, PAI inspection and Design Transfer.
This role will take technical inputs from the engineering staff and create technical documents in compliance with government regulations, industry standards and company requirements. Update and/or edit existing documents. Attend design project team meetings to collect technical data for use in creating documents.
Duties and Responsibilities:
- This role will develop design control documentation such as (but not limited to):
- User Needs/User Requirements/Design Inputs
- Design FMEA
- Test Method Validation Protocol/Report (Design)
- Design Verification protocol and report
- Design Validation protocol and report
- Design Traceability Matrix
- Owns and develop risk management documentation such as (but not limited to):
- Risk Management Plan & Report
- Risk Management File
- Bachelors of Engineering such as Mechanical or Material Science Engineering or equivalent
- 6 or more years of experience in the Medical Device industry in a role that required technical writing, and device design
- Demonstrated skills in technical writing; grammar and usage, form, organization of ideas, technical communications.
- Strong time management skills. Meeting deadlines is a must.
- Comfortable in a startup environment where process and role structure is frequently missing or changes rapidly.
- Documentation skills for data collection, process instructions, Engineering Change Orders, test protocols and reports, etc.
- Root Cause/Problem Solving techniques
- Familiarity with basic fabrication processes, molded parts and related medical device materials
- Communication with outside suppliers for the specification and acquisition of materials
- Manage a varied workload
- Proficient with MS Office
- Demonstrated alignment with and ability to put Intarcia’s Core Values into operation: Trust, Tenacity, Winning, Innovation, Care, Excellence
- Design Control Documentation (FDA DHF) experience
- Experience writing design control documents in a medical device setting preferred
- Device design, testing, conducting studies
- Experience with CFR 820
- Experience writing technical reports and good engineering notebook documentation skills are required
- Broad engineering knowledge in new product introduction, cost reduction, and quality improvements