R&D Engineer

Katalyst CRO; Raynham (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

Katalyst CRO is seeking an experienced professional to lead integration workstreams in medical device development. The role involves collaborating with engineering and regulatory teams to manage technical decisions and ensure compliance with design controls.

You'll need a Bachelor's degree in Mechanical or Biomedical Engineering, strong problem-solving skills, and at least 6 years of industry experience. The position offers opportunities to influence cross-functional teams and drive innovation in a collaborative setting.

Qualifications

• 6+ years of industry experience or 4+ years with an advanced degree.
• Proven ability to lead technical workstreams.
• Strong working knowledge of design controls, DHF documentation, and risk management.

Responsibilities

• Lead integration workstreams and manage technical decision-making.
• Support risk management documentation and validation activities.
• Collaborate cross-functionally with quality and regulatory teams.

Skills

Medical device development

Design controls

Problem-solving

Stakeholder management

Regulatory compliance

Education

Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or related field

Advanced degree preferred

Tools

Windchill or similar PLM/quality systems

Job description

Leading integration workstreams and shaping integration strategy with cross‑functional teams, collaborating closely with engineering leadership, technical teams, quality, manufacturing, supplier engineering, and regulatory stakeholders.

Roles & Responsibilities

• Lead integration workstreams including interface definition, requirements alignment, planning, and technical execution.
• Drive technical decision‑making across assigned deliverables in collaboration with engineering leadership.
• Own and ensure completion of design‑control deliverables including user needs, design inputs/outputs, and traceability.
• Support risk management documentation and mitigation strategy activities.
• Lead verification & validation (V&V) planning and execution activities.
• Support DHF development and maintenance in compliance with regulatory standards.
• Lead or oversee test method development and validation activities to ensure integration readiness.
• Conduct feasibility studies, prototype development, and iterative testing activities to optimize designs across device platforms.
• Perform root‑cause analysis, resolve complex technical issues, and proactively identify and mitigate integration risks.
• Partner cross‑functionally with quality, manufacturing, supplier engineering, and regulatory teams to drive execution and alignment.
• Influence cross‑functional stakeholders and provide technical leadership without direct line management responsibility.
• Collaborate closely with engineering managers, technical leads, engineers, and lab/testing support teams in a highly collaborative environment.

Requirements

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Materials Science, or related field. Advanced degree preferred.
• 6+ years of industry experience or 4+ years with an advanced degree.
• Strong experience in medical device development within a design controls environment.
• Experience with catheter‑based and/or single‑use medical devices.
• Proven ability to lead technical workstreams and influence cross‑functional teams.
• Strong working knowledge of design controls, DHF documentation, risk management, V&V, traceability, and change control.
• Ability to work independently with minimal guidance.
• Strong problem‑solving, communication, and stakeholder management skills.
• Experience with Windchill or similar PLM/quality systems preferred.
• Experience with DMR deliverables including prints, specification maps, and BOM creation preferred.
• Experience with test method development and validation preferred.Background in balloon catheter or catheter‑based systems preferred.
• Familiarity with Class II/III medical device regulations and quality systems preferred.
• Experience with product or technology integration activities preferred.
• Self‑starter with strong accountability, adaptability, and ability to operate in ambiguity.