Process Engineer at Actalent — NeverHard

Job DescriptionJob Description Job Title: Process Engineer Job Description This Process Engineer role focuses on leading the design, development, and implementation of new manufacturing processes and technologies within a highly regulated medical device environment. The engineer will work as part of a cross-functional project core team to ensure robust process development and validation, and to support successful transfer of projects and products into full-scale production. Responsibilities Lead the design, development, and implementation of new manufacturing processes and technologies that support medical device production. Apply structured problem-solving methods, lean principles, and best-practice process development techniques to drive product and process improvements. Collaborate closely with subject matter experts across the business to plan and execute process improvement activities that enhance existing manufacturing capabilities. Plan, implement, and coordinate new product introductions, including product design considerations, product specifications, process validations, identification of training needs, process and equipment layout, production procedures, material specifications, and material and packaging procurement. Design and introduce manufacturing processes for new products to increase capabilities and efficiencies and to deliver a competitive advantage for the organization and its customers. Conduct design of experiments (DOE) and use data-driven approaches to optimize processes and resolve complex manufacturing issues. Drive continuous improvement initiatives focused on process development, process improvement, troubleshooting, and assembly operations. Support new product development (NPD) and new product introduction (NPI) activities by developing and validating manufacturing processes for medical devices. Develop and execute validation and verification plans for new and existing processes, ensuring compliance with medical device quality and regulatory expectations. Design and execute test plans for new and existing processes, analyze results, and write detailed technical reports documenting findings, conclusions, and recommendations. Utilize vision systems and other inspection technologies to support process control and product quality in a medical device manufacturing environment. Troubleshoot manufacturing issues on the production floor and implement corrective and preventive actions to maintain stable and capable processes. Work closely with cross-functional teams to define material specifications, packaging requirements, and production procedures that support product quality and efficiency. Identify training needs associated with new or improved processes and support the development of training materials and documentation. Ensure all process development and validation activities align with internal standards and support smooth transfer of products to full production. Comply with all Health and Safety policies and procedures and promptly report unsafe working conditions to appropriate personnel. Essential Skills Proven experience in process engineering within a manufacturing environment. Strong experience in process development, including the ability to design and optimize manufacturing processes. Hands-on experience applying lean manufacturing principles and structured problem-solving methodologies. Expertise in design of experiments (DOE) and data-driven process optimization. Experience with process validation, including planning, execution, and documentation of validation activities. Mechanical engineering knowledge applicable to manufacturing processes and equipment. Demonstrated ability to support new product development (NPD) and new product introduction (NPI) in a production setting. Experience working with medical device manufacturing processes and associated quality and regulatory expectations. Ability to design and execute test plans for new and existing processes and to write detailed technical reports. Strong troubleshooting skills for resolving process and assembly issues on the manufacturing floor. Experience with continuous improvement initiatives focused on process and productivity enhancements. Capability to work with vision systems and other inspection technologies used in manufacturing. Strong communication and collaboration skills for working with cross-functional teams. Additional Skills & Qualifications Degree in Mechanical Engineering or a related technical discipline. Experience in medical device manufacturing, particularly in cardiology and vascular products, is highly advantageous. Familiarity with validation and verification methodologies for manufacturing processes and equipment. Understanding of clean room protocols and sterile manufacturing environments. Experience with assembly operations and troubleshooting in a high-volume production setting. Exposure to vision systems used for inspection and quality control in manufacturing. Ability to contribute to technology development initiatives and support cutting-edge medical device production. Strong documentation skills, including the ability to produce clear, comprehensive technical reports. Work Environment The role is based on a manufacturing floor during a plant start-up, where operations can be very fast-paced and occasionally chaotic as processes are established and optimized. Team members use swipe cards to access the building and are expected to swipe in and out for their shifts, with additional sign-in and sign-out procedures for security. The facility operates as a clean room environment with strict protocols and personal protective equipment requirements to maintain sterility and product safety. Business casual attire is required, with no gym clothing or denim permitted. Hair nets are worn in sterile areas, and additional nets are required for facial hair. Latex gloves and lab coats are provided and must be worn at all times in designated areas, with a laundry service available for lab coats. In warehouse areas, steel-toe footwear is required, while closed-toe shoes with socks are mandatory in production areas. No makeup, nail polish, or jewelry is allowed in the clean room environment to ensure product integrity. The facility is very clean and well lit, and employees have the opportunity to work with cutting-edge medical device technologies that support critical healthcare needs, including ventilator production. The organization emphasizes safety and maintains numerous precautions to protect employees while they contribute to meaningful, high-impact medical device manufacturing. Job Type & Location This is a Contract position based out of Mississauga, ON. Pay and Benefits The pay range for this position is $38.00 - $45.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Workplace Type This is a hybrid position in Mississauga,ON. À propos d'Actalent Actalent est un leader mondial dans les services d’ingénierie et de sciences ainsi que dans les solutions de talents. Nous aidons des entreprises visionnaires à faire progresser leurs initiatives d’ingénierie et de science grâce à l’accès à des experts spécialisés qui favorisent l’échelle, l’innovation et la rapidité de mise sur le marché. Avec un réseau de près de 20 000 consultants et 5 000 clients à travers les États-Unis, le Canada, l’Asie et l’Europe, Actalent dessert de nombreuses entreprises du Fortune 500. Nous sommes fiers d’être l’une des 500 meilleures firmes de conception de l’Engineering News-Record (ENR) pour nos services de conception en ingénierie et un lauréat du prix ClearlyRated Best of Staffing® tant pour le service client que pour les talents. Actalent est un employeur souscrivant au principe de l’égalité des chances et accepte toutes les candidatures sans tenir compte de la race, du sexe, de l’âge, de la couleur, de la religion, des origines nationales, du statut d’ancien combattant, d’un handicap, de l’orientation sexuelle, de l’identité sexuelle, des renseignements génétiques ou de toute autre caractéristique protégée par la loi. Si vous souhaitez faire une demande d’accommodement raisonnable, tel que la modification ou l’ajustement du processus de demande d’emploi ou d’entrevue à cause d’un handicap, veuillez envoyer un courriel à actalentaccommodation@actalentservices.com pour connaître d’autres options d’accommodement. Ordonnance sur l’égalité des chances de San Francisco: Conformément à l’Ordonnance sur l’égalité des chances de San Francisco, pour tous les postes situés dans la ville et le comté de San Francisco, nous examinerons les candidatures des personnes qualifiées ayant un casier judiciaire ou des antécédents criminels. Utilisation de l’intelligence artificielle (IA): Nous pouvons utiliser l’intelligence artificielle (IA) pour soutenir certaines étapes de notre processus d’embauche, notamment la recherche, la présélection et l’évaluation des candidatures. L’IA aide à analyser les candidatures et les qualifications, mais les décisions finales sont prises par notre équipe de recrutement. En soumettant votre candidature, vous reconnaissez et acceptez que celle-ci puisse être examinée à l’aide d’outils d’IA. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options. San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.