Senior Product Safety and Compliance Engineer- Medical Devices

About Us

SharkNinjais a global product design and technology company with a diversified portfolio of 5-star rated lifestyle solutions that positivelyimpactpeoples lives in homes around the world. Powered by two trusted global brands Shark and Ninja the company has a proventrack recordof bringing disruptive innovation to market and developing one consumer product after another has allowedSharkNinjato enter multiple product categories driving significant growth and market share gains. Headquartered in Needham Massachusetts with more than4100associates the companys products are sold at key retailers online and offline and through distributors around the world.

AI at SharkNinja

At SharkNinja were building an AI-native culture. Were not waiting for the future; were creating it. Our people are expected to experiment boldly adopt new tools and continuously raise whats possible to create meaningful impact for our consumers. If you believe the best way to do your job hasnt been invented yet youll fit right in.

The Senior Product Safety & Compliance Engineer will have a direct partnership with our global product developers and certification partners for all aspects of regulatory compliance and product certification. The candidate will be responsible for leading multiple certification projects from product concept to mass production ensuring that all market access requirements are met and that product designs employ appropriate risk mitigation solutions. This role includes active participation in medical device regulatory pathways alongside our consumer and commercial product portfolio.

Here are some of the EXCITING things youll get to do:

• Assist in owning the execution of certification activities and risk analysis for multiple new product development projects including FDA-regulated medical devices and products subject to EU MDR 2017/745.
• Support the preparation of regulatory filings including FDA 510(k) submissions and Technical Files/Design Dossiers and maintain Design History Files (DHF) in compliance with 21 CFR Part 820 Design Controls and ISO 13485 requirements.
• Establish project needs and deliverables for both our product development teams and third-party regulatory partners including Notified Bodies and FDA-accredited testing laboratories.
• Execute risk management activities in accordance with ISO 14971 including hazard identification risk estimation risk evaluation and residual risk documentation across the product lifecycle.
• Support usability engineering processes per IEC 62366-1 including participation in formative and summative evaluation planning for medical device products intended for home healthcare environments.
• Continuously evaluate project risk during the development process and establish contingency plans to overcome obstacles including regulatory strategy adjustments driven by classification questions or design changes.
• Lead weekly reviews for all assigned projects presenting status and associated project risks including certification timelines and Notified Body or FDA feedback cycles.
• Assure that all activities related to product certification commence and execute as planned and on schedule with attention to FDA review timelines and CE marking milestones under EU MDR.
• Support product development teams as a subject matter expert providing counsel on medical device-specific requirements including biocompatibility (ISO 10993 series) software lifecycle (IEC 62304) and home healthcare electrical safety (IEC).
• Assist in leading intradepartmental continuous improvement and special projects including contribution to post-market surveillance and complaint handling processes under 21 CFR Part 803 and EU MDR.
• Provide leadership and mentoring to junior team members on both consumer product certification and medical device regulatory frameworks.

Attributes & Skills

• Bachelors degree in Electrical Engineering Mechanical Engineering Biomedical Engineering Systems Engineering Materials Engineering Computer Science or a related technical discipline; RAC certification a plus.
• Relevant discipline context: Biomedical/Bioengineering backgrounds are well-suited to ISO 10993 biocompatibility and clinical evaluation; Systems Engineering to ISO 14971 risk management and design controls; Chemical/Materials Engineering to material selection substance compliance (REACH RoHS) and biocompatibility testing; Computer Science/Software Engineering to IEC 62304 software lifecycle and embedded systems compliance.
• Minimum 5 years of compliance or design-related experience with consumer commercial or medical electromechanical products.
• Strong working knowledge of medical device regulatory standards including:
• IEC 60601-1 and applicable collateral/particular standards (esp. IECfor EMC IECfor usability IEC for home healthcare environments)
• ISO 14971 Risk Management for Medical Devices
• ISO 13485 Quality Management Systems
• IEC 62366-1 Usability Engineering
• IEC 62304 Medical Device Software Lifecycle (where applicable)
• ISO 10993 series Biocompatibility Evaluation
• 21 CFR Part 820 FDA Quality System Regulation
• EU MDR 2017/745 classification rules Technical Documentation and UDI obligations
• FDA 510(k) submission processes
• Familiarity with international medical device regulations for key markets (Health Canada TGA Australia ANVISA Brazil) preferred.
• Experience with DFMEA and medical-grade risk management documentation (hazard analysis risk control verification residual risk justification).
• Experience interfacing with FDA Notified Bodies or accredited test laboratories preferred.

Must be able to:

• Operate comfortably in a fast-paced environment with regularly shifting priorities including simultaneous consumer and regulated-device program timelines.
• Thrive under pressure and want to be continuously challenged.
• Manage multiple projects simultaneously while maintaining continuous track of key details including regulatory submission status and design change impact assessments.
• Multi-task maintaining a continuous comprehensive understanding of project status across consumer certification and medical device regulatory workstreams.
• Present creative and technically sound solutions to complex problems including regulatory pathway questions where classification is ambiguous.
• Like to solve the puzzles and deliver on challenging assignments.
• Analyze operations and promote continuous improvement initiatives within a design control and post-market surveillance framework.
• Work with conviction and demonstrate strength on key positions while collaborating and compromising where appropriate.
• Work and think independently with moderate supervision and generate ideas within their area of expertise.
• Make sound decisions utilizing all available information including benefit-risk trade-offs required under ISO 14971.
• Communicate complex technical and regulatory information to audiences with varying technical understanding.
• Adapt well to change including evolving regulatory guidance and new product category entries into regulated spaces.
• Present at a high level to all levels within the organization demonstrating comfort and confidence in collaborating with colleagues and superiors.
• Desire ownership and possess a want to take the last shot of the game mentality.