Job Description
RESPONSIBILITIES
SERVE AS LEAD DEVELOPMENT ENGINEER ON ONE OR MORE EU MDR PROJECT TEAMS. ENSURE THAT REQUIRED DOCUMENTATION/EVIDENCE IS AVAILABLE IN COORDINATION WITH ACTIVITIES, AND INTERFACING WITH PROJECT TEAM MEMBERS INCLUDING ENGINEERING, REGULATORY, MARKETING, CHANGE MANAGEMENT, POST MARKET SURVEILLANCE, MICROBIOLOGY, BIOCOMPATIBILITY, CLINICAL AFFAIRS AND PRODUCTION.
ASSURE PRODUCT DESIGN HISTORY FILES MEET THE REGULATORY REQUIREMENTS OF MEDICAL DEVICE REGULATIONS (MDR 2017/745, INTERNAL QUALITY SYSTEM AND OTHER APPLICABLE REGULATIONS).
WORK INDEPENDENTLY TO UPDATE LEGACY PRODUCT DESIGN HISTORY FILE TO COMPLY WITH EU MDR 2017/745 FOCUSING ON PRODUCT DESIGN DOCUMENTS. THIS INCLUDES BUT IS NOT LIMITED TO PRODUCT LISTS AND PRODUCT SPECIFICATIONS.
ANALYZE POST MARKET DATA AND UPDATE DESIGN INPUTS AS REQUIRED BASED ON CURRENT DESIGN AND DATA.
ASSESS OR PERFORM, WHERE NECESSARY, 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 THE PACKAGING TEAM TO ENSURE PACKAGING MATERIAL RISK IS MITIGATED AND CAPTURED WITH PRODUCT SPECIFICATIONS AS REQUIRED BY INTERNAL PROCEDURES AND REGULATIONS.
ACTIVELY PARTICIPATE WITH CROSS FUNCTIONAL TEAMS TO MITIGATE RISK TO ACCEPTABLE LEVEL WITH ADEQUATE DOCUMENTATION. THIS INCLUDES BUT IS NOT LIMITED TO MICROBIOLOGY, BIOCOMPATIBILITY AND CLINICAL.
EVALUATE MATERIALS USING CAD MODELS, CHEMICAL COMPOSITION CHARTS, MATERIAL DATA SHEETS, EUROPEAN CHEMICAL AGENCY AND OTHER INTERNAL AND EXTERNAL REFERENCES TO DETERMINE AND DOCUMENT HAZARDOUS AND NON-HAZARDOUS STATE OF MATERIALS.
IDENTIFY PRODUCTS INCLUDED IN PROJECT BASED ON PLANNING AND PROJECT CHARTERS/PRODUCT FAMILIES.
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.
SERVE AS SME DURING INTERNAL AND EXTERNAL AUDITS.
ASSIST IN THE DEVELOPMENT OF THE QUALITY SYSTEM BUT WRITING DOCUMENTS, RELEASING DOCUMENTS AND PROVIDING TRAINING.
OTHER DUTIES AS ASSIGNED.
REQUIREMENTS
EXPERIENCE CREATING PRODUCT DESIGN SPECIFICATIONS (I.E. DRAWINGS USING UNIGRAPHICS/NX).
WORKING KNOWLEDGE OF THE ANATOMY
WORKING KNOWLEDGE OF ORTHOPEDIC IMPLANTS AND INSTRUMENTS (I.E. HIPS, KNEES, PLATES, SCREWS, NAILS, ETC.)
ABILITY TO APPLY KNOWLEDGE OF FDA’S GUIDANCE DOCUMENT FOR DESIGN CONTROL, ISO 14971 RISK MANAGEMENT; AND OTHER APPLICABLE STANDARDS TO SUSTAINING ENGINEERING PROJECTS
CLEAR AND CONCISE WRITTEN AND VERBAL COMMUNICATION
ABILITY TO MULTI-TASKS, PRIORITIZE, MEETS/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 PREVENTIVE ACTION EXPERIENCE INCLUDING ROOT CAUSE ANALYSIS
EXPERIENCE WITH WORKING WITH CROSS FUNCTIONAL TEAMS
ABILITY TO WORK INDEPENDENTLY TO COMPLETE ASSIGNED PROJECT DELIVERABLES ON TIME
EXPERIENCE WORKING IN A REMOTE ENVIRONMENT
STANDARDS AND REGULATIONS:
EU MDR 2017/745
EU MDD 93/42/EEC
ISO 13485
EXPERIENCE WITH MATRIX PLM SYSTEM PREFERRED
EXPERIENCE WITH SAP PREFERRED
POWER-BI-DATA VISUALIZATION EXPERIENCE PREFERRED
THE COMPANY IS AN EQUAL OPPORTUNITY EMPLOYER AND WILL CONSIDER ALL APPLICATIONS WITHOUT REGARDS TO RACE, SEX, AGE, COLOR, RELIGION, NATIONAL ORIGIN, VETERAN STATUS, DISABILITY, SEXUAL ORIENTATION, GENDER IDENTITY, GENETIC INFORMATION OR ANY CHARACTERISTIC PROTECTED BY LAW.
Company Description
OpenArc is a technology consulting firm providing industry-leading technical talent placement, software development, and technology strategy services to clients nationwide. Through a unique blending of people and software, OpenArc has a business practice that delivers amazing enterprise, mobile and consumer-facing apps and the best talent for contract, contract-to-hire and direct placements for clients and partners alike. Staffed with the most-trusted recruiting experts, elite software developers, UI/UX designers and market experts, our team provides clients with the best resources, the right techniques and world-class support resulting in powerful measurable success. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.