Sr Process Engineer - Exempt

Join Our Team

Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It's no accident – we work hard to cultivate a workforce that reflects our patients and partners. We believe it's the only way to drive healthcare forward and remain a global leader in medical technology and solutions. Danvers, the trusted partner for development and scaling of leading-edge delivery systems, transforming pellets into unparalleled performance and enabling
*** to serve more patients worldwide.

Be a part of a dynamic team that designs and develops manufacturing processes for new delivery systems from concept through design transfer and product launch. This process development team is committed and driven in our mission to revolutionize the way we manufacture delivery systems while producing a high-quality product for our patients and customers.

The ideal candidate will be a seasoned professional with a passion for advanced manufacturing and the development of manufacturing processes during product development phases. The candidate will be involved with process development, setting up manufacturing operations, and interfacing cross-functionally with other key engineering expertise to develop a product.

In this role, you will be part of a team but will be able to work independently with limited supervision to determine and develop approaches to solutions. You will coach and review the work of lower-level professionals. You may manage projects/processes. You will communicate with senior internal and external customers and suppliers. Your work will involve collaboration and dynamic interactions with R&D and Design Assurance regarding products in the development pipeline and with operation team members for new or iterative product implementation.

Problems and issues faced are difficult and may require understanding of multiple issues, job areas, or specialties.

• Process Technologies: Lead the exploration and development of new process technologies that may be incorporated into new product development projects or existing manufacturing lines. Analysis provided is in-depth in nature and often provides recommendations on process improvements.
• Process Development: Lead new product development by designing and developing manufacturing processes for new products that facilitate ease of manufacturing while producing quality, cost-effective products with optimized yields. Such activities include, but are not limited to:
• Manufacturing Studies: Work with engineering team on studies to characterize process inputs to drive development of critical manufacturing/process specifications that are both robust and meet quality expectations. Use appropriate statistical support and Design of Experiments (DOE).
• Equipment and Fixture Development: Identify equipment and fixture needs within pilot line and/or manufacturing operations.
• Documentation: Generate required documentation in support of manufacturing products and processes. These include engineering protocols/reports, PFMECAs, and manufacturing instructions. Ensure compliance with internal procedures, GMP, and regulations.
• Qualification and Validation: Generate and execute plans for equipment qualification and process validation. Lead test method development and validation where needed.

• Bachelor's Degree in a related engineering discipline (i.e., mechanical, biomedical, industrial, materials science) with 4-7 years of experience or Advanced Degree with 4 years of experience.

• Previous medical device experience
• Demonstrated problem-solving and critical thinking experience
• Solid oral and written communication skills, including presentation skills
• Solid interpersonal skills and ability to work in a cross-functional team environment
• Solid understanding of statistical techniques and analysis
• Design for Reliability and Manufacturability (DRM) experience
• Demonstrated computer skills such as Minitab, Excel, Word, and Project
• Process Validation (IQ/OQ/PQ) and Test Method Validation experience

Together, we can change healthcare worldwide. At ***, we push the limits of what technology, therapies, and services can do to help alleviate pain, restore health, and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with…