Process Mechanical Engineer - Verification & Validation

About Adjutant Solutions Group

Adjutant Solutions Group (ASG) specializes in developing, qualifying, and commercializing drug delivery systems within biomedical industries. We provide integrated scientific and business solutions aimed at fostering healthier, safer, and more prosperous communities. Our core values emphasize service, client success, curiosity, respect, integrity, and accountability, promoting a diverse, collaborative, and growth-focused team environment.

Role Summary

The Process Mechanical Engineer will be responsible for developing, designing, implementing, and verifying assembly and packaging processes for commercial biomedical devices. This role demands a solid grasp of process mechanical engineering principles and independent work capabilities, alongside effective communication and collaboration within project teams. Experience with medical device verification and validation, including design verification, validation support, test method development, and technical documentation across product lifecycles aligned with regulatory and quality standards, is highly desirable.

Key Responsibilities

• Maintain expertise in process mechanical engineering trends and collaborate with suppliers, acquirers, and solution delivery teams.
• Apply current knowledge of medical device design controls, verification and validation methodologies, and relevant standards such as ISO 13485, ISO 14971, and FDA design controls.
• Provide technical input and collaboration in injection molding tooling activities, staying updated with emerging technologies such as micromolding.
• Assist project leadership by defining technical scope, priorities, execution order, and aligning team skills, while communicating technical progress and challenges.
• Participate in design activities by understanding stakeholder needs, defining solution architectures, and conducting design reviews.
• Manage engineering tasks including mechanical and electrical component identification and evaluation, CAD drawing analysis, and risk management activities like FMEA, FTA, and control plan updates.
• Lead planning and execution of design verification for medical devices and combination products.
• Develop and validate assembly and packaging solutions ensuring production readiness and compliance documentation.
• Oversee procurement, fabrication, assembly, and integration to support production implementation.
• Engage actively in verification and testing efforts, documenting process items and performing design of experiments.
• Maintain stringent adherence to industry standards, safety, and quality requirements.
• Advocate for acquirers by engaging suppliers, advising on manufacturing and design impacts, and facilitating communication among all stakeholders.

Qualifications

• Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or a related discipline.
• 2 to 5 years’ relevant experience in mechanical engineering or related fields.

Knowledge and Skills

• In-depth understanding of process mechanical engineering concepts including material flows, quality and safety by design, pneumatics, actuators, and sensors.
• Experience with assembly operations, power distribution (electrical and pneumatic), fabrication, machining, and tolerance verification.
• Strong critical thinking and analytical reasoning skills incorporating mathematical validation and strategic alignment.
• Proficiency in systems thinking, systems analysis, and systems engineering approaches.
• Excellent communication skills, both oral and written, with effective listening and objective expression.
• Project management capabilities with time management, organizational skills, and problem-solving aptitude.
• Demonstrated collaboration, conflict resolution, accountability, and high integrity in work products.

Abilities and Behaviors

• Capability to perform process engineering tasks independently.
• Leadership in developing new plastic injection tooling projects meeting performance and cosmetic standards.
• Collaborate with cross-functional teams (supply management, product design, industrial design, manufacturing) on manufacturability and aesthetics.
• Research and incorporate new materials, finishing technologies, and manufacturing methods.
• Provide accurate cost estimations for prototypes and production including tooling and assembly processes.
• Exemplify core values of accountability, integrity, respect, curiosity, client service, and commitment to enriching others’ lives.