New · posted Nov 14
Takeda · Medical Devices
Senior Manager, Software Device Quality
- Lexington, MA
- On-site
- Full-time
- Manager
The role
The Senior Manager, Software Device Quality is a seasoned quality and technical leader responsible for supporting software medical devices and combination products across the full product lifecycle - from design and development through manufacturing, distribution, and post-market support. This role ensures compliance with all applicable quality and regulatory requirements and provides leadership across key quality processes.
How you will contribute
- Partner with product development teams to lead quality activities across design controls, including risk management, design inputs/outputs, verification/validation, and design transfer
- Provide quality oversight and approval for change control activities, including design updates, enhancements, bug fixes, and infrastructure changes
- Maintain Design History Files (DHF) and Technical Files
- Support global regulatory submissions and approvals for software and combination products
- Oversee verification and validation activities to ensure compliance and product quality
- Provide quality ownership and oversight of risk management files (ISO 17971) and Design and Development files (ISO 13485)
- Integrate cybersecurity risk management into the software and device risk management process, including threat modeling, security risk assessments, and SBOM/vulnerability management, in alignment with ISO 14971, AAMI TIR57, and FDA premarket and post market cybersecurity guidance
- Support and contribute to device development process and QMS improvement
- Lead or support regulatory inspections and audits (ISO 13485, and IEC 62304, MDSAP, MDR, and other global requirements)
- Lead investigations into quality events, using root cause analysis, corrective action plans and effectiveness checks.
- Monitor product performance through post-market surveillance and drive inspection readiness as well as continuous improvement across QMS
What you bring to Takeda
- Bachelor’s degree in biomedical, mechanical, electrical engineering, quality engineering or related technical field
- 7+ years of experience in medical device quality/ Engineering experience within medical devices or pharmaceutical industries
- Working knowledge of quality systems and standards relevant to medical devices (e.g. ISO 13485, and IEC 62304 MDSAP, ISO 14971, MDR/MDD, 21 CFR Part 820)
- Working knowledge of medical device cybersecurity and how it applies to risk management (e.g., security risk assessment, threat modeling, vulnerability management, and post market surveillance)
- Experience with regulatory submissions and commercial product development
- Experience working with external manufacturing partners and driving effective investigations and root cause analysis
- Demonstrated ability to partner seamlessly with cross-functional teams to deliver quality outcomes across the product lifecycle
- Strong cross-functional collaboration and project/program management experience
What you need
Preferrednice to have
- Advanced degree in engineering or quality related discipline. Software medical device or Quality IT background
- Collaborative leadership style focused on listening, coaching, team development, and integrating multiple perspectives
- Strong business engagement style, wit ability to collaborate effectively with both technical and non-technical stakeholders.
- Experience leading discussions and interactions during regulatory inspections.
- Adaptable and decisive, with ability to respond effectively to changing business priorities, technologies and regulatory requirements.
Core Competencies
- Technical Expertise: Strong scientific and analytical skills to assess complex data and make risk-based quality decisions
- Leadership: Ability to influence, build relationships, and drive results across global, cross-functional teams
- Decision-Making: Confident decision-making in complex and ambiguous environments, with a focus on continuous improvement
- Collaboration: Proven ability to partner effectively across functions and geographies
- Innovation: Drives process improvements through product and quality insights
- Adaptability: Thrives in dynamic environments and effectively manages complexity and change
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Empowering our people to shine:
Pay
$137,000 – $215,270 a year
Employer providedU.S. Base Salary Range
$137,000.00 - $215,270.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
For information about our benefits, please click here.
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
Where you'll work
Lexington, MAOn-siteOpen in Maps (opens in a new tab)
More jobs in Lexington, MAWorking conditions
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
From the posting
About Takeda
For Location
Lexington, MA
Job Exempt
YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Equal opportunity, accessibility and legal noticesTakeda's statements, word for word
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Job intelligence
The context around this role
Live data · November 14, 2026
Salary intelligence
How the pay compares
This role's midpoint is 10% above the US median for Design Quality & Assurance roles at this level.
This roleEmployer provided
Manager roles in the US7 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $137,000 | — | $215,270 |
| All US (middle half) | $148,500 | $159,500 | $176,500 |
This role: Takeda's own published range. Comparisons: the base pay employers published on open Design Quality & Assurance roles at the same level on Regulatory Jobs, November 14, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Design Quality & Assurance
The general path across 74 open Design Quality & Assurance roles on Regulatory Jobs, with the titles they carry most. Not Takeda's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 37 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Quality systems and risk11
- Collaboration and leadership11
- GMP and compliance6
- Regulatory submissions4
- Data and digital systems4
- Investigations and CAPA2
- Validation and qualification2
- Lab testing and methods1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Design Quality & Assurance work in medical devices, led by the eight this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices, aligned with ISO 13485Named in the posting
- ISOISO 14971(official source, opens in a new tab)Application of risk management to medical devicesNamed in the posting
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devicesNamed in the posting
- IECIEC 62304(official source, opens in a new tab)Software life cycle processes for medical device softwareNamed in the posting
- FDAFDA cybersecurity in medical devices(official source, opens in a new tab)Quality system considerations and premarket content for device cybersecurityNamed in the posting
- EUEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation: CE marking, technical documentation, vigilanceNamed in the posting
- FDA21 CFR Part 4(official source, opens in a new tab)Current good manufacturing practice for combination productsNamed in the posting
- FDAMDSAP(official source, opens in a new tab)The Medical Device Single Audit Program shared by five regulatorsNamed in the posting
- IECIEC 62366-1(official source, opens in a new tab)Application of usability engineering to medical devices
- FDA21 CFR Part 56(official source, opens in a new tab)Institutional review boards for FDA-regulated clinical investigations
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- FDAFDA human factors guidance(official source, opens in a new tab)Applying human factors and usability engineering to medical devices
- IECIEC 60601-1(official source, opens in a new tab)Basic safety and essential performance of medical electrical equipment
- ISOISO 10993-1(official source, opens in a new tab)Biological evaluation of medical devices within a risk management process
- FDAFDA 510(k)(official source, opens in a new tab)Premarket notification: showing substantial equivalence to a legally marketed device
Company hiring pulse
Takeda on Regulatory Jobs
- 69
- Open roles
- 69
- Distinct roles
- 16
- Locations
By discipline
- Clinical27 39%
- Regulatory25 36%
- Quality17 24%
By level
- Director43 61%
- Senior & Principal11 16%
- Manager10 14%
More roles at Takeda
- View role
Senior Analyst, R&D Quality Data Analytics
Boston, MA · HybridSenior & PrincipalPharmaceuticals$90K–$141K
- View role
Medical Director, Pharmacovigilance, Inflammation
Boston, MA · HybridDirectorPharmaceuticals$237K–$373K
- View role
Associate Medical Director, Clinical Science – Inflammation TAU
Cambridge, MADirectorPharmaceuticals$199K–$312K
- View role
Clinical Science Lead
Boston, MADirectorPharmaceuticals$177K–$278K
Similar Design Quality & Assurance roles elsewhere
- View role
Senior Robotics Verification & Validation (V&V) Engineering Manager
Johnson & JohnsonBoston, MA · HybridManagerMedical Devices$140K–$242K
- View role
Manager, Operations Quality - NPI Programs (Hybrid - Acton)
InsuletActon, MA · HybridManagerMedical Devices$111K–$166K
- View role
Sustaining Design Quality Engineering Manager
Smith+NephewMansfield, MA · HybridManagerMedical Devices$97K–$145K
- View role
Sr. Manager, Design Assurance Engineering
EnvistaPomona, CA +1 moreManagerMedical Devices$152K–$165K
Senior Manager, Software Device Quality at Takeda
Open until filled. $137K–$215K a year, employer provided.