Manufacturing/Process Development Engineer I-II

Become a vital member of the NP team at nextern and contribute to the advancement of groundbreaking medical device technologies. This position is ideal for individuals passionate about exploring new processes, tackling technical challenges, and engaging directly with cutting-edge manufacturing technologies. If you possess curiosity, a collaborative spirit, a…

Join nextern as a Senior Process Development Engineer, where you will play a pivotal role in the cross-functional leadership of process development for intricate technologies, ensuring the seamless transition of products into production.Key Responsibilities:Examine design specifications and convert requirements into reliable manufacturing processes to enhance the quality and reliability of final products.Evaluate process capabilities, identify key improvement opportunities, and implement enhancements to existing manufacturing processes.Utilize technical expertise to innovate, design, and develop processes, tooling, and equipment.Establish and release deliverables as per individual design and development plans.Conduct and release Process Failure Modes and Effects (PFMEA) analyses, along with Master Validation Plans (MVP).Define and release equipment installation, performance, and operational qualification (IQ/PQ/OQ) protocols and reports.Employ advanced statistical techniques (e.g., Design of Experiments, normality assessment, measurement systems analysis) to assess process capability, validate measurement methods, and facilitate data-driven decision-making for product and process enhancements.Provide design for manufacturing (DFM) input for assembly and component specifications.Create and compile training materials; lead training sessions.Collaborate with relevant departments and teams to develop product design and tooling processes that ensure efficient production methods.Engage with external vendors to clarify product specifications; coordinate the procurement of equipment, materials, and/or parts; assess products to confirm they align with specifications and quality standards.Estimate production timelines, staffing needs, and associated costs to inform management decisions.Project future manufacturing needs and potential.Analyze data for process investigations, productivity enhancements, cost analysis, and regulatory filings; document and convey results.Perform additional related duties as assigned by management.

Nextern is seeking a skilled and experienced Principal Process Development Engineer to join our dynamic process development engineering team. In this pivotal role, you will provide engineering support for the definition, design, process development, and production transfer of a diverse range of innovative medical devices. Collaborating closely with internal engineers, operational teams, and key client stakeholders, you will play a crucial role in our commitment to excellence.Key Responsibilities:Identify and evaluate technologies that align with the manufacturing requirements of new product development initiatives.Establish design criteria and prepare comprehensive documentation, including User Requirements Specifications and Equipment Specifications for highly automated systems.Oversee the design and fabrication processes of automated manufacturing equipment by external vendors.Lead the planning and execution of Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation Qualification (IQ), and process characterization.Act as the primary technical liaison for specific projects, effectively communicating with both internal and external stakeholders.Coordinate production release activities for finished goods and components, ensuring all necessary BOMs, routings, and ERP information are accurate.Develop solutions for complex engineering challenges and implement significant process improvements independently to enhance operational performance.Manage large-scale projects, including delegation and review of team outputs, while occasionally taking on leadership responsibilities.Employ quality tools such as DOE, SPC, hypothesis testing, and capability studies to monitor and enhance manufacturing processes.Identify opportunities for process improvements and provide technical solutions through hands-on analysis and interaction with designated processes.Utilize project management skills to oversee process development, ensure vendor compliance with schedules, and validate projects are completed on time and within budget.Create detailed documentation, test plans, and reports that substantiate technical decisions, including qualifications, risk assessments, and work instructions.Collaborate with product development engineering to integrate lessons learned into the design of new products.Provide training and certification for trainers as required.Lead initiatives to explore and develop new technologies related to combination products.

Nextern is seeking an experienced Director of Process Development to spearhead the design, optimization, and scaling of manufacturing processes for cutting-edge catheter-based and electromechanical medical devices. This pivotal role requires a strategic leader who can effectively engage with cross-functional teams, ensuring the establishment of robust, compliant, and cost-efficient processes from the initial stages of development all the way through to commercialization.The successful candidate will possess extensive technical knowledge in medical device process development, exceptional leadership skills, and a proven history of facilitating manufacturing readiness within regulated environments.

Salary: $27.00 - $33.00/hourNextern is an innovative and expanding medical device manufacturing company dedicated to excellence and advancement in the field. We prioritize our team members' growth and foster a collaborative environment where your contributions are valued. If you are passionate about quality, teamwork, and making a meaningful impact, we would love for you to be part of our team.Key Responsibilities:Constructs products through all stages of Product Realization in both cleanroom and general manufacturing settings.Assists in equipment design for usability, characterization, qualification, and validation tasks.Employs manual and/or automated measurement tools and equipment.Drafts and refines manufacturing procedures and travelers.Effectively resolves problems in a timely manner.Understands cause-and-effect relationships in process development.Maintains a positive demeanor and operates within company guiding principles.Follows the Code of Conduct Policy relevant to the role.Performs additional duties as assigned by management.

As a Traffic Engineer at Houston Engineering, Inc., you will play a pivotal role in designing and optimizing transportation systems to enhance traffic flow and improve safety. You will collaborate with a dynamic team of professionals to deliver innovative solutions that meet the needs of our clients and the community. Your expertise in traffic engineering will be critical in assessing traffic patterns, conducting studies, and implementing traffic management strategies.

Join our dynamic team at Houston Engineering, Inc. as a Senior Transportation Engineer. In this pivotal role, you will lead the design and implementation of transportation projects, ensuring efficiency, safety, and sustainability. Collaborate with multidisciplinary teams to develop innovative solutions that meet the needs of our clients and communities.

Join our innovative team at nextern as a Senior Systems Engineer. In this pivotal role, you will leverage your extensive experience to design, implement, and optimize complex systems that drive our projects forward. You will collaborate with cross-functional teams, ensuring that our systems meet the highest standards of performance, reliability, and scalability.

Join Houston Engineering, Inc. as a Senior Traffic Engineer and play a vital role in shaping transportation solutions that impact communities. In this dynamic position, you will utilize your expertise to analyze traffic patterns, design safe roadways, and collaborate with interdisciplinary teams to advance innovative projects.As a Senior Traffic Engineer, you will lead traffic studies, develop reports, and present findings to clients and stakeholders. Your contributions will ensure that our transportation systems are efficient, safe, and sustainable.

The Manufacturing Engineer is pivotal in optimizing production methodologies, ensuring adherence to the company's rigorous quality standards. This role encompasses a comprehensive analysis of manufacturing workflows, pinpointing enhancement opportunities, and crafting innovative systems and solutions to bolster productivity while safeguarding product integrity.Key Responsibilities: Engage with cross-functional teams to conceptualize and execute manufacturing enhancements. Perform process simulations and assessments to uncover bottlenecks and inefficiencies. Create and uphold process documentation, including work instructions, flow diagrams, and technical specifications. Drive continuous improvement initiatives utilizing lean manufacturing principles and Six Sigma methodologies. Facilitate new product introductions by devising manufacturing processes. Conduct root cause analyses for production challenges and formulate corrective measures. Evaluate equipment performance and recommend upgrades or replacements as needed. Educate production personnel on new processes and technologies. Ensure adherence to safety regulations and compliance standards in all manufacturing activities. Collect and evaluate data regarding production efficiency, quality metrics, and labor expenses to inform strategic decision-making.

Join Houston Engineering, Inc. as a Civil Engineering Technician and become a vital part of our innovative team. In this full-time role, you will assist in the design, development, and execution of various civil engineering projects. Your responsibilities will include drafting plans, conducting site assessments, and collaborating closely with engineers and project managers to ensure successful project outcomes.

Join Houston Engineering, Inc. as a Professional Engineer (PE) specializing in Water Resources. In this pivotal role, you will apply your engineering expertise to manage and design water resource projects that are vital for sustainable development. You will collaborate with a dynamic team of professionals to innovate and enhance our water management practices, ensuring compliance with environmental regulations.Your responsibilities will include conducting hydrological analyses, preparing engineering reports, and engaging with clients to deliver tailored solutions. If you are passionate about water conservation and possess a strong foundation in engineering principles, we invite you to apply.

Nextern is actively seeking a talented Senior Design Assurance Engineer to join our innovative team in Maple Grove, Minnesota. This exciting opportunity offers competitive compensation and a comprehensive benefits package that supports your professional growth and well-being.As a Senior Design Assurance Engineer, you will play a critical role in ensuring the quality and compliance of our new product development initiatives throughout the entire product lifecycle. You will also support ongoing activities for investigational and commercial device manufacturing, including audits and post-market surveillance, to maintain an accurate and compliant Design History File. Your expertise in quality systems and regulatory standards will be essential as you interact with both internal teams and Nextern customers to drive continuous improvement.Key Responsibilities:Act as a core team member for product development projects, focusing on key deliverables such as:Design Controls (planning, inputs/outputs, verification, design reviews, etc.) in accordance with 21 CFR 820.30Risk Management (Planning/Reporting, Hazard Analysis, FMEA/Risk Assessment) in line with ISO 14971Equipment and Material QualificationDevelopment and validation of Test MethodsCollaborate on and approve engineering deliverables and work ordersProvide expertise on biocompatibility testing per ISO 10993, or coordinate with external Contract Research OrganizationsPlan and conduct testing in support of new product development, including Design Verification and Performance ValidationFacilitate the transition of designs from R&D to manufacturingEnsure the maintenance of up-to-date product Design History Files (DHF)Guide project teams in best practices for Quality and Regulatory complianceIdentify opportunities for efficiency and redundancy reduction within Quality System requirementsReview and approve changes, ensuring documentation of impacts and actions takenInvestigate and document product complaints, interacting with customers as neededServe as a Subject Matter Expert (SME) during audits for QMS processes and product DHFsLead changes in Product Lifecycle Management (PLM) as required

Join our dedicated team at Houston Engineering, Inc. as a Senior Environmental Scientist, where you will play a pivotal role in environmental assessment and management projects. Your expertise will contribute to sustainable practices and innovative solutions that positively impact the environment.As a Senior Environmental Scientist, you will collaborate with a diverse team of professionals, utilizing your analytical skills to conduct field studies, analyze data, and prepare comprehensive reports. You will have the opportunity to lead projects, mentor junior team members, and engage with clients to ensure the successful delivery of high-quality environmental services.

Join Houston Engineering, Inc. as a Senior Wetland Scientist and play a pivotal role in environmental conservation. You will be responsible for conducting wetland assessments, habitat restoration projects, and collaborating with state and federal agencies to ensure compliance with environmental regulations.