Diagnostic Devices Engineer

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Job Description

Position Overview:

We are seeking a motivated and detail-oriented Diagnostic Devices Engineer to lead Diagnostic Device technical project management within our dynamic team. This role focuses on the project management of remediation tasks, lifecycle management of diagnostic services, and support for new product development and assessments within the diagnostic devices sector. The ideal candidate will have a passion for medical technology, experience in diagnostic device and/or assay development, and a desire to ensure compliance with evolving FDA and IVDR regulations. Additionally, they should enjoy collaborating across projects as part of a global team.

Key Responsibilities:

• Oversee lifecycle management activities for ongoing and expanding diagnostic services.

• Lead project management of remediation tasks to ensure compliance with changing regulatory landscapes such as FDA and IVDR.

• Collaborate with cross-functional teams to gather data, analyze results, and implement improvements.

• Maintain up-to-date documentation and records related to diagnostic devices.

• Conduct research and stay informed about industry trends, standards, and regulatory requirements.

• Identify opportunities for process improvement in diagnostic service/device development at Takeda and work with leadership and cross-functional teams to implement effective solutions to enhance efficiency and quality.

• Provide technical support and troubleshooting assistance for diagnostic devices.

Qualifications:

• Bachelor's degree in Biomedical Engineering, Biochemistry, Molecular Biology, or a related field.

• 3-5 years of experience in the biotech or pharmaceutical industry.

• Proven project management and organizational skills.

• Ability to work effectively both independently and as part of a team.

• Strong analytical and problem-solving abilities.

• Excellent written and verbal communication skills.

• Detail-oriented with a commitment to maintaining high-quality standards.

Preferred Experience:

• 3-5 years of relevant professional experience within the medical device or diagnostics industry

• Relevant experiences with diagnostic assay development.

• Demonstrated experience in performing concept prototyping, feasibility testing, and assessments

• Familiarity with product lifecycle management software and tools.

• Basic understanding of quality control and validation processes for diagnostic devices.

• Experience in cross-functional teams as technical SME, including but not limited to legal, regulatory, quality, clinical, medical, and commercial stakeholders.

Takeda Compensation and Benefits Summary

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.

For Location:

Lexington, MA

U.S. Base Salary Range:

$108,500.00 - $170,500.00

EEO Statement

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.

Locations

Lexington, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes

It 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.