Sr Compliance Engineer--- Medical Device

Title: Sr. Compliance Engineer
Hiring Organization: Connexion Systems & Engineering

• Duration: Perm
• Pay rate: $135-145k
• Job Location: Littleton, MA
• Job# 15567

Job Summary
Provide compliance related engineering plans, solutions and services to product development and sustaining product teams to assure conformity with US and International standards for regulatory, safety, and performance. This includes IEC60601-1 (and associated particular & collateral standards), environmental regulations, FDA 21 CFR 820, ISO13485, European Union MDR and various regional other standards related to medical laser and RF technology.  Own engineering and documentation activities related to international registrations to maximize realization of key business opportunities.  Establish design control documentation tools and methodologies to optimize compliance speed, efficiency, and cost. 
Essential Duties and Responsibilities
The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.

• Participate in cross-functional Product Development teams to assure project plans, product/system requirements, and design inputs/outputs meet applicable standards.  Provide focused engineering support to solve problems and/or evaluate tradeoffs during design process.
• Provide gap analysis for existing products based on current and future standards releases, including potential solutions, timeline and cost associated with required updates/changes.  Lead CIP efforts required to close gaps via internal and external partnerships.
• Support regulatory product registrations by providing compliance related input.
• Act as primary liaison between engineering team and external compliance partners and/or regional registration contacts.  Manage all aspects associate with outside testing and evaluations from RFQ to final report and follow-up.
• Create and execute verification and validation test plans to evaluate product/ subassemblies.
• Support operations in resolving EOL plans at component or subassembly level
• Manage design reviews related to compliance and quality plans.
• Support Risk Management activities related to compliance for various Medical Devices.
• Support Usability and Human Factors product evaluations.
• Maintain expert level knowledge of key regulations and standards world-wide.
• Support cross functional teams with environmental compliance regulations.
• Support Cleaning/disinfection/ sterilization and biocompatibility activity as needed.
• Embody and deliver the “Exceptional Everyday”

Qualifications (Select the minimum qualifications required for this position to successfully achieve business requirements)
Education

• Bachelor’s degree required in BSEE or equivalent

Specific Area of Study:
Experience

• 5 to 8 years relevant experience in compliance, product development design, operations or quality role.

Specific Related Experience:

• Minimum 3 years’ experience with Medical Device compliance associated with commercial capital equipment and accessories. 
• Laser and RF experience is a plus.
• Prior experience working for (or with) NRTL agencies.

Skills:

• Knowledge of emissions and immunity engineering practices
• Expertise developing Medical Devices in compliance with IEC60601-1 (and associated particular and collateral standards), Environmental regulation, FDA 21 CFR 820, CDRH, ISO13485, EU MDR.
• Strong professional skills and cooperative positive attitude is a must.
• Foresees problems rather than simply reacting to them.
• Uses independent judgment to assess project technical status and determine the means to overcome challenges
• Confidently makes competent decisions and takes suitable actions when presented with situations that are unclear, or problems that are unfamiliar.
• Must be able to multi-task, meet tight deadlines and prioritize changing demands in a fast-paced, entrepreneurial environment

• Takes responsibility for projects, requirements, and schedules. Must be self-motivated and possess good organizational and communication skills.
• Energetic, enthusiastic, enjoys the challenge of creative design.
• Proficiency in report writing, analysis, and compliance procedures.
• Thorough understanding of regulatory frameworks.
• Skilled in business operations or project management.
• The ability to communicate complex ideas verbally and in writing.
• Solid technical knowledge and understanding of product/process design.

Physical Demands
The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. 

• Sit; use hands to finger, handle or feel objects, tools, or controls.
• Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl.
• Lifting/pushing/pulling and carrying products weighing up to 45 pounds
• Potential Exposure to moving mechanical parts, vibration and/or moderate noise levels.
• Potential Exposure to hazardous chemicals or other materials.
• Safety Shoes compliant with site specific policies/procedures must be worn in designated areas