MDR Design Engineer 3

Summary:

• Assure product design history files meet the regulatory requirements of Medical Device Regulations (MDR 2017/745, internal quality system and other applicable laws).
• Work to update legacy product design history file to align with EU MDR 2017/745 focusing on product design documents. This Product lists and product specifications.
• Ability to analyze post market data and update design inputs based on current design and data.
• Assess or perform design verification and validation to support acceptable design risk mitigation, which may include hazardous materials assessment, human factors' analysis, and lifetime evaluations.
• Work with Research and Development to produce evidence that products meet the requirements of applicable ISO, ASTM, IEC specifications.
• Aid other groups to ensure that literature and labels reflect requirement of EU MDR
• Work with packaging team to ensure packaging material risk is mitigated and captured with Product specifications by internal procedures and regulations.
• Actively participate with multi-functional teams to mitigate risk to acceptable level with adequate documentation. This includes but is not limited to Microbiology, Biocompatibility and Clinical.
• Ability to identify products included in project based on planning a project charter/product family.
• Apply knowledge of FDA's Guidance document for Design Control, ISO 14971 Risk Management; IEC 60601-1 Medical Electrical Equipment and collateral standards, IEC 62366 Usability, and IEC 62304 Software Lifecycle; and other applicable standards to sustaining engineering projects.
• Serve as primary development engineer on one or more EU MDR project teams. Ensure that required documentation/evidence is available in coordination with activities, and working with project team members including engineering, regulatory, marketing, change management, post market surveillance, microbiology, biocompatibility, Clinical Affairs, and production.
• Prepare, evaluate, and critique technical documentation including design justifications and rationales based on sound scientific or engineering principles.
• Makes decisions and proposes solutions based on calculated risks identified through data analysis.
• Evaluate procedures and processes within the quality system to identify areas for improvement. Recommend solutions to identified problems.
• Coordinate activities with Management and Project Management Office (PMO) and report regularly on the progress of activities.
• Participate in meeting departmental goals and objectives, on time project delivery per release project schedule
• Work with counterparts in other divisions and countries.
• Work to respond to questions posted by the Regulatory Affairs group and agencies with specified time.

Required Education:

• Bachelor's degree in engineering or equivalent scientific field

Experience:

• Preferred experience includes 5+ years at medical device company serving as a Product Development Engineer supporting design control teams with a BS degree and 2+ years' experience crafting product design specifications (i.e., drawings using Uni-graphics/NX).
• Alternative considerations include 4+ years in product engineering experience in a GMP environment. 2+ years' experience with a Master's degree.

Required Qualifications:

• Clear and concise written and verbal communication.
• Ability to multi-task, prioritize, meet/exceed deadlines and hold themselves accountable.
• Self- starter, with the ability to work independently
• Software programs - Microsoft Word, PowerPoint, Excel, Project.
• Experience with managing documents within electronic PLM system.
• Corrective and Preventative action experience including root cause analysis.

Standards and Regulations:

• EU MDR 2017/745
• EU MDD 93/42/EEC
• ISO 13485
• 21 CFR Part 820
• ISO 14971
• 21 CFR Part 820
• FDA's guidance document on Design Controls

Preferred Qualifications:

• Remote working environment experience
• Experience with Matrix PLM system
• Experience with SAP
• ASQ certification as a Certified Quality Biomedical engineer
• Six-Sigma or equivalent green/blackbelt certification
• Power-BI-Data Visualization

Standards and Regulations:

• IEC 62366
• IEC 62304

Travel:

• Occasional domestic travel may be required less than 10%

Comments:

This job description is an outline of the major recurring responsibilities of the job and is not intended to be all-inclusive of the work to be performed. The incumbent(s) will typically perform other related job objectives and special assignments.

About Us:

Smith+Nephew is a global medical technology company. We design and manufacture technology that takes the limits off living! We support healthcare professionals to return their patients to health and mobility, helping them to perform at their fullest potential!

Care, Collaboration, & Courage:

Care means that we show empathy and understanding for each other, our customers, and patients.

Collaboration means we work together as a team, based on mutual trust and respect.

Courage is about continuous learning, innovation, and accountability.

Veterans are strongly encouraged to apply.

Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.