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Form of workJob Description
InnoTECH Staffing is looking to hire a Principal Product Development Engineer for an exciting start-up in the Newton Wellesley, MA area.
This is a Hybrid role.
Do you have a passion for pushing the boundaries of innovation in the medical device industry? Are you ready to lead the charge in creating cutting-edge, life-saving technologies? If so, we have a thrilling opportunity for you.
What You'll Do
As a Principal Medical Device Design Engineer, you will be the hands-on technical leader who shapes the future of medical device design. Your role is instrumental in achieving user requirements and design specifications through the following exciting responsibilities:
1.Master the Art of CAD Modeling: Bring your expertise in CAD modeling (Solidworks) to the forefront, shaping the visual and functional aspects of our life-changing medical devices. Create technical drawings, perform tolerance stacks, and conduct in-depth analyses.
2.Engineering Prowess: Apply your functional knowledge of mechanical engineering principles, materials science, and structural mechanics to create products that are not just groundbreaking but also reliable and manufacturable.
3.Project Leadership: Take the lead in all project phases, from concept and feasibility to development, transfer to manufacturing, qualifications, and product launch. You'll be the driving force behind every milestone.
4.Regulatory Compliance: Devise strategies for verification and validation activities that adhere to FDA guidelines, ensuring our products meet the highest standards of safety and efficacy.
5.Testing and IP Development: Develop innovative tests and methods, author test protocols, execute them flawlessly, and contribute to the creation of intellectual property that paves the way for future advancements.
6.Collaboration: Collaborate with external design engineering partners and contract manufacturers to seamlessly transfer designs to manufacturing, ensuring a smooth transition.
7.Problem Solving: Apply critical and independent thinking to tackle complex technical issues. Identify root causes, conduct investigational test protocols, implement corrective actions, and author detailed investigational reports.
8.Project Ownership: Take ownership of key aspects of the project plan, ensuring deadlines are met and milestones are achieved efficiently.
9.Effective Communication: Clearly convey complex technical information to inform a diverse set of stakeholders about organizational risks and opportunities.
What You'll Need
To excel in this role and contribute to our groundbreaking work, you should bring the following qualifications:
1.Educational Background: A degree in Mechanical Engineering or a closely related engineering discipline.
2.Experience: 10-12 years of related experience, showcasing your expertise in medical device design.
3.Communication Skills: Excellent written and verbal communication skills to effectively convey your ideas and findings.
4.Design Knowledge: A proven track record in complex electro-mechanical/opto-mechanical medical device design for manufacture and transfer to manufacturing, with strong knowledge of manufacturing techniques, mechanisms, materials, and tolerancing.
5.Regulatory Familiarity: Experience with medical device design controls, including 21 CFR 820 and ISO 13485. Familiarity with IEC 60601 and IEC 62304 is desirable.
6.CAD Proficiency: Proficiency and efficiency with 3D CAD software, especially SolidWorks.
7.PMA Submissions: Experience with PMA submissions is desirable, demonstrating your ability to navigate the regulatory landscape.
8.Photonics/Optical Engineering: Experience or knowledge in photonics/optical engineering is desirable, reflecting your versatility in the field.
9.Onsite Presence: Be ready to work onsite at least 60% of the time, actively participating in our dynamic team environment.
If you're ready to embark on an exciting journey in medical device design, where your expertise and innovation can make a difference in people's lives, we invite you to apply. This is your opportunity to lead, create, and transform the future of healthcare through groundbreaking technology. Join us, and let's shape the future together.
