Novocure Inc
Senior Manager, Product Management
Novocure Inc, Portsmouth, New Hampshire, United States, 00215
JOB SUMMARY
Novocure provides cancer patients with a novel treatment for aggressive cancers using Tumor Treating Fields (TTFields). The Senior Manager, Product Management will lead cross‑functional strategy and readiness for consumable equipment and accessories (both sterile and non‑sterile) that are integral to Novocure's medical device systems. The ideal candidate will have direct experience with Class II and/or Class III medical devices and their consumables, operating within highly regulated development environments under FDA and EU MDR frameworks. This includes responsibility from concept through end‑of‑life for consumables supporting device performance, patient usability, and regulatory compliance.
This is a full‑time, exempt position located in our Portsmouth, NH office.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Act as the product owner for all consumables and accessories (e.g., transducer arrays, bags, and related components) associated with the Optune device
Partner with R&D and Quality to define user needs, design inputs, and risk mitigation for consumables and accessories, ensuring compliance with relevant standards and regulations (ISO 13485, ISO 14971)
Collaborate with cross‑functional teams to provide engineering and other teams with guidance on new product requirements and improvements
Support development, validation, and manufacturing transfer of consumables (sterile and non‑sterile) for Class II/III medical devices
Ensure that Novocure products meet patient and market needs through coordinated launches and lifecycle management activities
Generate and coordinate target product profiles upfront in the product cycle, defining value propositions and clinical/commercial benefits
Collaborate with Regulatory Affairs to ensure appropriate classification, labeling, and submission documentation for consumable products
Develop and maintain methods for capturing and analyzing patient feedback, product costs/tradeoffs, and market opportunities to guide roadmap decisions
Lead efforts to incorporate metrics into launches focused on improving user experience, safety, and performance at scale
Strongly collaborate with project managers, development teams, and commercial teams throughout the development cycle to lead all aspects of productization
Act as the connecting link between Product Development and Commercial/Medical teams to ensure alignment from design to market deployment
QUALIFICATIONS/KNOWLEDGE
Degree in engineering, biomedical engineering, or related field; MBA preferred
Minimum 8 years of experience in product management or development within the medical device industry, with demonstrated involvement in consumable or disposable product lines (sterile and/or non‑sterile)
Experience with wearable medical devices strongly preferred
Hands‑on experience with Class II or Class III medical devices in a regulated environment (FDA QSR, EU MDR)
Knowledge of design control (21 CFR 820.30), risk management (ISO 14971), sterility validation, and ISO 13485 quality systems
Proven ability to collaborate with cross‑functional and global teams including R&D, Quality, Regulatory, Manufacturing, and Supply Chain
Prior experience leading or supporting 510(k), PMA, or CE‑Mark submissions involving consumable components is highly beneficial
Strong product knowledge combined with good acumen related to clinical and commercial value propositions
Experience with globally dispersed teams and managing external development or manufacturing partners
OTHER
Following Novocure's values and code of conduct
Acting always in line with Novocure's confidentiality policies and procedures
Completion of assigned trainings in due time
Assure compliance with applicable standards, regulations, laws, and guidelines relevant to the position
Conduct additional tasks in the course of ongoing improvement initiatives or projects as advised by management
Ability to lift up to 20 pounds
Up to 30% (domestic and international) travel may be required.
Novocure is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state, or local law. We actively seek qualified candidates who are protected veteran and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Novocure is committed to providing an interview process that is inclusive of our applicant's needs. If you are an individual with a disability and would like to request an accommodation, please email NovocureRecruitingEEO@novocure.com
ABOUT NOVOCURE Our vision
Patient‑forward: aspiring to make a difference in cancer.
Our patient‑forward mission
Together with our patients, we strive to extend survival in some of the most aggressive forms of cancer by developing and commercializing our innovative therapy.
Our patient‑forward values
innovation
focus
drive
courage
trust
empathy
#LI-RJ1
#J-18808-Ljbffr
This is a full‑time, exempt position located in our Portsmouth, NH office.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Act as the product owner for all consumables and accessories (e.g., transducer arrays, bags, and related components) associated with the Optune device
Partner with R&D and Quality to define user needs, design inputs, and risk mitigation for consumables and accessories, ensuring compliance with relevant standards and regulations (ISO 13485, ISO 14971)
Collaborate with cross‑functional teams to provide engineering and other teams with guidance on new product requirements and improvements
Support development, validation, and manufacturing transfer of consumables (sterile and non‑sterile) for Class II/III medical devices
Ensure that Novocure products meet patient and market needs through coordinated launches and lifecycle management activities
Generate and coordinate target product profiles upfront in the product cycle, defining value propositions and clinical/commercial benefits
Collaborate with Regulatory Affairs to ensure appropriate classification, labeling, and submission documentation for consumable products
Develop and maintain methods for capturing and analyzing patient feedback, product costs/tradeoffs, and market opportunities to guide roadmap decisions
Lead efforts to incorporate metrics into launches focused on improving user experience, safety, and performance at scale
Strongly collaborate with project managers, development teams, and commercial teams throughout the development cycle to lead all aspects of productization
Act as the connecting link between Product Development and Commercial/Medical teams to ensure alignment from design to market deployment
QUALIFICATIONS/KNOWLEDGE
Degree in engineering, biomedical engineering, or related field; MBA preferred
Minimum 8 years of experience in product management or development within the medical device industry, with demonstrated involvement in consumable or disposable product lines (sterile and/or non‑sterile)
Experience with wearable medical devices strongly preferred
Hands‑on experience with Class II or Class III medical devices in a regulated environment (FDA QSR, EU MDR)
Knowledge of design control (21 CFR 820.30), risk management (ISO 14971), sterility validation, and ISO 13485 quality systems
Proven ability to collaborate with cross‑functional and global teams including R&D, Quality, Regulatory, Manufacturing, and Supply Chain
Prior experience leading or supporting 510(k), PMA, or CE‑Mark submissions involving consumable components is highly beneficial
Strong product knowledge combined with good acumen related to clinical and commercial value propositions
Experience with globally dispersed teams and managing external development or manufacturing partners
OTHER
Following Novocure's values and code of conduct
Acting always in line with Novocure's confidentiality policies and procedures
Completion of assigned trainings in due time
Assure compliance with applicable standards, regulations, laws, and guidelines relevant to the position
Conduct additional tasks in the course of ongoing improvement initiatives or projects as advised by management
Ability to lift up to 20 pounds
Up to 30% (domestic and international) travel may be required.
Novocure is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state, or local law. We actively seek qualified candidates who are protected veteran and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Novocure is committed to providing an interview process that is inclusive of our applicant's needs. If you are an individual with a disability and would like to request an accommodation, please email NovocureRecruitingEEO@novocure.com
ABOUT NOVOCURE Our vision
Patient‑forward: aspiring to make a difference in cancer.
Our patient‑forward mission
Together with our patients, we strive to extend survival in some of the most aggressive forms of cancer by developing and commercializing our innovative therapy.
Our patient‑forward values
innovation
focus
drive
courage
trust
empathy
#LI-RJ1
#J-18808-Ljbffr