R&D Engineer

Katalyst CRO; Raynham (MA); On-site; USD 120,000 - 160,000; Full time

Job summary

Katalyst CRO is seeking an experienced professional to lead integration workstreams, drive design controls, and manage V&V activities across multiple device platforms. You will collaborate with engineering leadership, quality, manufacturing, and regulatory teams to ensure robust DHF documentation and compliant risk management.

The role emphasizes proactive risk mitigation, strong problem-solving, and the ability to operate in ambiguity within a highly collaborative setting.

Qualifications

• 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.
• Background in balloon catheter or catheter-based systems preferred.
• Familiarity with Class II/III medical device regulations and quality systems preferred.
• Self-starter with strong accountability, adaptability, and ability to operate in ambiguity.

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.

Skills

Project leadership

Medical device development

Design controls

V&V planning

Risk management

Regulatory knowledge

Systems integration

Cross-functional collaboration

PLM/Windchill

DMR deliverables

Test method development

Education

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

Tools

Windchill PLM

Job description

• The role involves leading integration workstreams, supporting design and quality system integration activities, and collaborating closely with engineering leadership, technical teams, quality, manufacturing, supplier engineering, and regulatory stakeholders.
• This position plays a key role in shaping integration strategy and ensuring successful execution of downstream deliverables in a highly collaborative environment.
  
• 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.
  

Job Description

• The role involves leading integration workstreams, supporting design and quality system integration activities, and collaborating closely with engineering leadership, technical teams, quality, manufacturing, supplier engineering, and regulatory stakeholders.
• This position plays a key role in shaping integration strategy and ensuring successful execution of downstream deliverables in a highly collaborative environment.
  

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.