Vacature Life Sciences

ASSEMBLY DEVICES PROJECT MANAGER - INDIANNAPOLIS, IN

If you are passionate about engineering and you have an Entrepreneurial Mindset, TMC USA is Seeking a Self-Motivated Assembly Devices Project Manager who thrives in fast-paced environments.

| Your challenges?

• Lead and manage the entire lifecycle of healthcare assembly device projects, ensuring compliance with regulatory standards, such as FDA guidelines and ISO 13485.
• Collaborate with cross-functional teams, including engineering, manufacturing, quality assurance, regulatory affairs, and supply chain, to define project requirements, deliverables, and resource allocation.
• Develop and maintain detailed project plans, including work breakdown structures, critical path analysis, and risk assessments, to ensure smooth project execution while adhering to regulatory requirements.
• Monitor project progress, identify potential bottlenecks or risks, and proactively implement corrective measures to keep projects on track and within compliance guidelines.
• Conduct regular project status meetings, provide updates to stakeholders, and facilitate effective communication between team members, ensuring everyone is aligned and informed.
• Manage project budgets, including resource allocation, cost estimation, and tracking expenditures, to ensure projects are delivered within budgetary constraints.
• Collaborate with the engineering team to define and implement assembly device design and manufacturing improvements, ensuring efficiency, quality, and adherence to healthcare regulations.
• Foster a collaborative and productive work environment, promoting teamwork, professional growth, and knowledge sharing among project team members.
• Stay updated on the latest developments and advancements in healthcare assembly device manufacturing technologies, industry regulations, and quality control processes.
• Work closely with regulatory affairs to ensure that all necessary documentation, including regulatory submissions, technical files, and design history files, are accurately prepared and maintained.
• · Coordinate with clinical teams and key stakeholders to incorporate user feedback and ensure assembly devices meet the specific needs and requirements of healthcare professionals and patients.

| What do we expect from you?

• Bachelor's degree in engineering, healthcare management, or a related field. Advanced degree is a plus.
• Proven experience 5 years in project management within the healthcare industry, preferably in medical device manufacturing.
• Strong knowledge of healthcare assembly device manufacturing processes, including design, prototyping, testing, and production, with a focus on regulatory compliance.
• Excellent organizational and time management skills, with the ability to prioritize tasks and manage multiple projects simultaneously.
• Proficient in project management methodologies, tools, and software (e.g., Microsoft Project, JIRA, Agile).
• Strong leadership and team management skills, with the ability to motivate and inspire cross-functional teams to achieve project objectives.
• Exceptional problem-solving and decision-making abilities, with a keen attention to detail.
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with stakeholders at all levels, including regulatory bodies.
• Proactive mindset with a results-oriented approach, constantly seeking opportunities for process improvement and optimization.
• Familiarity with relevant healthcare industry standards and regulations, such as FDA regulations, ISO 13485, and Good Manufacturing Practices (GMP), is essential.

| What does TMC USA have to offer?

On top of giving you all the advantages of working in a start-up environment, at TMC USA you will benefit from the support of a strong well established international company:

• W2 full-time position
• Competitive compensation: base salary with monthly bonus (based on individual performance)
• Medical, dental and vision coverage
• Generous ETO (Earned Time Off) plan
• 401k with matching
• Yearly training personal budget for Coaching & Education
• International work opportunity

| What can you expect from TMC?

TMC is an international high-tech consultancy company that brings expertise to their clients in order to support them with the realization of their technological challenges. As such, TMC is operating as an expert center at the disposition of its clients, and we help them to be more competitive in an ever more global and faster changing technological world.

At TMC we believe that people are the driving force behind technological innovation. That is why we want to create the best possible conditions for tech talents to thrive in. We offer you a challenging and stimulating work environment in which you can be the director of your own career.

As an Employeneur you are part of our TMC family. Next to our outstanding technical expertise, fun and engagement are meaningful parts of our culture.

| Why choose for Employeneurship?

We are truly unique thanks to our Employeneurship model which is a true innovation for the High Technology consulting business. It is the business relationship of the 21^st century for high skilled technical professionals. It is built around 5 main pillars:

• You will have a permanent employment contract, offering you stability and security
• You will get to know your market value and have a share in the profit your work generates thanks to the individual profit sharing
• We will support you with a one-on-one coaching and trainings designed to help you develop your entrepreneurial skills
• The competence cells structure, provides you with a strong meaningful and relevant network
• The entrepreneurial lab: a playground for new ideas and a potential launching for start-ups

TMC is an equal opportunity employer and values diversity. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.