Onsite Role Job Overview This position delivers engineering solutions to sustain production of implantable and consumable medical devices. Responsibilities include leading cross-functional teams to support design and supplier changes, CAPAs, NCRs, Product Complaints and other compliance projects. This job requires knowledge of medical device regulations including design controls. Job Responsibilities and Essential Duties
- Leads design change projects to improve product performance, reduce cost and enhance the manufacturability of commercially released medical devices.
- Leads CAPAs, NCRs and Product Complaints by investigating and addressing potential product design issues as appropriate.
- Leads Design Reviews at appropriate stages to evaluate adequacy of design requirements, assess the capability of the design to meet requirements and identify and resolve problems.
- Works cross-functionally on design changes, process improvement projects and quality/compliance initiatives.
- Creates and executes protocols for Design Verification and Validation activities, engineering studies and feasibility studies.
- Aids in the selection, design and evaluation of process and test equipment.
- Creates and executes protocols and reports for process validation, test method validation, equipment qualification and gage R&R studies.
- Processes change orders to create or revise design input and output documentation.
- Performs product testing and engineering studies to support design change and investigational activities.
- Performs Out of Specification (OOS) investigation reports for test failures.
- Supports Out of Tolerance (OOT) investigations for equipment calibration failures.
- Supports the development and revision of part specifications and other design documentation.
- Maintains the Design History File (DHF) and Device Master Record (DMR) throughout the lifecycle of the product based on changes to the product design or manufacturing process.
- Successfully leads project teams by identifying and mitigating project risks and tracking all project deliverables to completion.
- Provides technical expertise throughout the supplier selection and evaluation process.
- Mentors junior-level staff members.
- Provides updates to management on project status.
- Supports internal and external audits.
- Contributes to the team effort by accomplishing related tasks as needed.
Minimum Requirements
- Bachelor's degree in Engineering or scientific discipline, such as chemical, biomedical, materials, or mechanical engineering.
- A minimum of five years' experience in the medical device industry (or other regulated industry) with relevant experience in design controls, production and process controls and/or R&D or related areas.
- Experience leading cross-functional project teams and being a decision-maker.
- Knowledge of 21 CFR Part 820 and standards relevant to medical devices.
- Strong experience with Microsoft Office applications (Word/Excel/PowerPoint) is required.
Required Knowledge, Skills and Abilities
- Demonstrated ability to solve technical challenges with cross-functional teams.
- Strong analytical and problem-solving skills.
- Strong communication and collaboration skills.
- Self-motivated with the ability to accomplish project goals with minimal supervision.
- Experience with Agile PLM and Minitab desired.
- Knowledge of Good Documentation Practices (GDP) required.
- Excellent verbal and written communication skills.
Environmental/Safety/Physical Work Conditions
- Ensures environmental consciousness and safe practices are exhibited in decisions.
- May work extended hours during peak business cycles.
- This position may require 5-10% travel.
The physical demands described here are a representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 95,000 - 120,000 annually + 10% STIP #LI-YA2 #LI-Onsite
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Getinge
Feb 15, 2025