Katalyst CRO
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Engineering Project Manager
role at
Katalyst CRO
Job Description Lead cross‑functional teams in complex engineering assignments, ensuring compliance with medical device regulations and effective project execution. This role requires a strong focus on project management, collaboration, and problem‑solving across traditional product lines.
Responsibilities
Independently plan, execute, and direct cross‑functional engineering projects, adapting standard engineering principles to develop innovative solutions.
Manage projects consisting of cross‑functional teams (including but not limited to regulatory, risk management, quality, technical communications, and supplier quality).
Oversee all financial aspects of product development, including capital expenditures and cross‑functional expenses.
Identify and resolve complex problems, developing new solutions as needed for project roadblocks.
In‑depth understanding of FDA regulations, ISO standards, and other relevant guidelines governing medical device labeling and compliance.
Familiarity with project management frameworks (e.g., Agile, Waterfall) and tools (e.g., Gantt charts, project management software).
Strong foundation in engineering principles relevant to medical device design and development.
Knowledge of QMS practices and documentation requirements.
Understanding of the roles and responsibilities of various departments involved in medical device development.
Requirements
Bachelor’s degree in engineering or a related field.
8–10 years of relevant experience in project management, with a focus on medical devices.
2–5 years of experience in matrix management.
Thorough, up‑to‑date knowledge of multiple engineering disciplines.
Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
Proven ability to manage multiple projects simultaneously, ensuring timely delivery within budget.
Strong analytical and problem‑solving skills to identify issues and develop effective solutions.
Excellent verbal and written communication skills for diverse audiences.
Ability to lead and motivate cross‑functional teams.
Meticulous attention to detail in reviewing labeling documentation.
Ability to make informed decisions in evaluating engineering techniques.
Flexibility to adapt to changing project requirements and industry trends.
Strong organizational skills with effective prioritization.
Ability to build and maintain positive working relationships.
Commitment to staying current with industry developments.
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Engineering Project Manager
role at
Katalyst CRO
Job Description Lead cross‑functional teams in complex engineering assignments, ensuring compliance with medical device regulations and effective project execution. This role requires a strong focus on project management, collaboration, and problem‑solving across traditional product lines.
Responsibilities
Independently plan, execute, and direct cross‑functional engineering projects, adapting standard engineering principles to develop innovative solutions.
Manage projects consisting of cross‑functional teams (including but not limited to regulatory, risk management, quality, technical communications, and supplier quality).
Oversee all financial aspects of product development, including capital expenditures and cross‑functional expenses.
Identify and resolve complex problems, developing new solutions as needed for project roadblocks.
In‑depth understanding of FDA regulations, ISO standards, and other relevant guidelines governing medical device labeling and compliance.
Familiarity with project management frameworks (e.g., Agile, Waterfall) and tools (e.g., Gantt charts, project management software).
Strong foundation in engineering principles relevant to medical device design and development.
Knowledge of QMS practices and documentation requirements.
Understanding of the roles and responsibilities of various departments involved in medical device development.
Requirements
Bachelor’s degree in engineering or a related field.
8–10 years of relevant experience in project management, with a focus on medical devices.
2–5 years of experience in matrix management.
Thorough, up‑to‑date knowledge of multiple engineering disciplines.
Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
Proven ability to manage multiple projects simultaneously, ensuring timely delivery within budget.
Strong analytical and problem‑solving skills to identify issues and develop effective solutions.
Excellent verbal and written communication skills for diverse audiences.
Ability to lead and motivate cross‑functional teams.
Meticulous attention to detail in reviewing labeling documentation.
Ability to make informed decisions in evaluating engineering techniques.
Flexibility to adapt to changing project requirements and industry trends.
Strong organizational skills with effective prioritization.
Ability to build and maintain positive working relationships.
Commitment to staying current with industry developments.
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